{"ctNumber":"2024-513457-70-00","ctStatus":"Ended","startDateEU":"2023-09-08","endDateEU":"2025-06-26","decisionDate":"2024-09-24T11:42:21.282","publishDate":"2026-07-04T03:40:27.311245923","ctPublicStatusCode":8,"authorizedApplication":{"authorizedPartI":{"id":79231,"rowSubjectCount":85,"rowCountriesInfo":[{"eutctId":100000000557,"name":"United States","isoNumber":840,"isoAlpha2Code":"US","isoAlpha3Code":"USA","current":true},{"eutctId":100000000556,"name":"United Kingdom","isoNumber":826,"isoAlpha2Code":"GB","isoAlpha3Code":"GBR","current":true},{"eutctId":100000000329,"name":"Australia","isoNumber":36,"isoAlpha2Code":"AU","isoAlpha3Code":"AUS","current":true}],"products":[{"id":324629,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11559479","euMpNumber":"PRD10167923","prodAuthStatus":1,"sponsorProductCode":"BPL-003","euSubstNumber":"SUB299297","nameOrg":"BECKLEY PSYTECH LTD","productSubstances":[{"productPk":"11559479","substancePk":"372627","nameOrg":"BECKLEY PSYTECH LTD","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","substanceEvCode":"SUB299297","synonyms":["BPL-003 benzoate","5-Methoxy-N,N-dimethyltryptamine benzoate","5-MeO-DMT benzoate"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"otherMedicinalProduct":"Chemical","evCode":"PRD10167923","sponsorProductCodeEdit":"BPL-003","miaNumber":"IMP12512/0001","devices":[],"characteristics":["11"],"allSubstancesChemicals":true},{"id":324630,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11559592","euMpNumber":"PRD10167932","prodAuthStatus":1,"sponsorProductCode":"BPL-003","euSubstNumber":"SUB299297","nameOrg":"BECKLEY PSYTECH LTD","productSubstances":[{"productPk":"11559592","substancePk":"372627","nameOrg":"BECKLEY PSYTECH LTD","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","substanceEvCode":"SUB299297","synonyms":["BPL-003 benzoate","5-Methoxy-N,N-dimethyltryptamine benzoate","5-MeO-DMT benzoate"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"otherMedicinalProduct":"Chemical","evCode":"PRD10167932","sponsorProductCodeEdit":"BPL-003","miaNumber":"IMP12512/0001","devices":[],"characteristics":["11"],"allSubstancesChemicals":true}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, with Open Label Extension, in Patients with Treatment Resistant Depression","fullTitleTranslations":[{"id":5895755,"uuid":"1f997cf5-c93b-4c56-8b07-e3e725d3583a","attributeTranslation":"Badanie poczwórnie maskowane, mające na celu ustalenie dawki oraz ocenę skuteczności i bezpieczeństwa stosowania donosowej postaci BPL-003, z przedłużeniem prowadzonym metodą otwartej próby, u pacjentów z depresją oporną na leczenie","language":19,"languageDescription":"Polish"},{"id":5895754,"uuid":"1f997cf5-c93b-4c56-8b07-e3e725d3583a","attributeTranslation":"Eine vierfach-blinde Dosisfindungsstudie zur Untersuchung der Wirksamkeit und Sicherheit von intranasalem BPL-003 mit Open-Label-Extension bei Patienten mit behandlungsresistenten Depressionen","language":29,"languageDescription":"German (Germany)"},{"id":5895756,"uuid":"1f997cf5-c93b-4c56-8b07-e3e725d3583a","attributeTranslation":"Estudio cuádruple ciego de determinación de la dosis para evaluar la eficacia y la seguridad de BPL-003 intranasal, con extensión abierta, en pacientes con depresión resistente al tratamiento","language":7,"languageDescription":"Spanish"}],"publicTitle":"Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients with Treatment Resistant Depression","publicTitleTranslations":[{"id":5895791,"uuid":"34cbde2c-091a-4e5b-a97c-3cf4f2be5c7b","attributeTranslation":"Badanie oceniające skuteczność i bezpieczeństwo stosowania donosowej postaci BPL-003 u pacjentów z depresją oporną na leczenie","language":19,"languageDescription":"Polish"},{"id":5895790,"uuid":"34cbde2c-091a-4e5b-a97c-3cf4f2be5c7b","attributeTranslation":"Estudio para evaluar la eficacia y la seguridad de BPL-003 intranasal en pacientes con depresión resistente al tratamiento","language":7,"languageDescription":"Spanish"},{"id":5895789,"uuid":"34cbde2c-091a-4e5b-a97c-3cf4f2be5c7b","attributeTranslation":"Studie zur Untersuchung der Wirksamkeit und Sicherheit von intranasalem BPL-003 bei Patienten mit behandlungsresistenten Depressionen","language":29,"languageDescription":"German (Germany)"}],"shortTitle":"BPL-003-201","secondaryIdentifyingNumbers":{"nctNumber":{"id":363369,"number":"NCT05870540"},"additionalRegistries":[{"id":363370,"number":"2022-003743-10","otherRegistryName":"EudraCT","ctRegistryCode":"6"}]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"Therapeutic Exploratory (Phase II)","trialCategoryId":70570},"medicalCondition":{"partIMedicalConditions":[{"id":80697,"medicalCondition":"Treatment-Resistant Depression (TRD)","medicalConditionTranslations":[{"id":5895655,"uuid":"5cbe3531-0b2f-4e9a-a26c-9d960674ed61","attributeTranslation":"Depresión resistente al tratamiento","language":7,"languageDescription":"Spanish"},{"id":5895654,"uuid":"5cbe3531-0b2f-4e9a-a26c-9d960674ed61","attributeTranslation":"Depresją oporną na leczenie","language":19,"languageDescription":"Polish"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000024349,"version":"21.1","level":"PT","termName":"Major depression","classificationCode":"10057840","organClass":100000004873,"active":false}]},"trialObjective":{"trialScopes":[{"code":"6","trialScopeId":233521},{"code":"9","trialScopeId":233520},{"code":"4","trialScopeId":233522},{"code":"5","trialScopeId":233519},{"code":"3","trialScopeId":233523}],"mainObjective":"CORE study:  To determine the efficacy of [CCI] mg of BPL-003 given with psychological support to participants with treatment--resistant depression (TRD)\n\nOpen label extension (OLE): To determine the safety of [CCI] BPL-003 given with psychological support to participants with TRD","mainObjectiveTranslations":[{"id":5895787,"uuid":"dbe220fc-04eb-4cc9-b9aa-fc51d6d6aeb4","attributeTranslation":"BADANIE GŁÓWNE: Określenie skuteczności [CCI] mg BPL-003 podawanego z jednoczesnym wsparciem psychologicznym uczestnikom z depresją oporną na leczenie (treatment-resistant depression, TRD) //\n\nPrzedłużenie prowadzone metodą otwartej próby (OLE): Określenie bezpieczeństwa [CCI] BPL-003 podanego z jednoczesnym wsparciem psychologicznym uczestnikom z TRD","language":19,"languageDescription":"Polish"},{"id":5895788,"uuid":"dbe220fc-04eb-4cc9-b9aa-fc51d6d6aeb4","attributeTranslation":"CORE: Determinar la eficacia de [CCI] mg de BPL-003 administrados con apoyo psicológico a participantes con depresión resistente al tratamiento (DRT) //\n\nExtensión sin enmascaramiento (OLE): Determinar la seguridad de [CCI] BPL-003 administrada con apoyo psicológico a participantes con DRT","language":7,"languageDescription":"Spanish"}],"secondaryObjectives":[{"id":264349,"number":1,"secondaryObjective":"CORE:  To determine the efficacy, including early onset, of BPL-003 given with psychological support to participants with TRD","secondaryObjectiveTranslations":[{"id":5895793,"uuid":"561e1dcc-97a5-47c0-8efb-96c3f4a2292a","attributeTranslation":"CORE: Determinar la eficacia, incluido el inicio temprano, de BPL-003 administrado con apoyo psicológico a participantes con DRT","language":7,"languageDescription":"Spanish"},{"id":5895792,"uuid":"561e1dcc-97a5-47c0-8efb-96c3f4a2292a","attributeTranslation":"CORE: Określenie skuteczności, w tym wczesnego początku, BPL-003 podawanego z jednoczesnym wsparciem psychologicznym uczestnikom z TRD","language":19,"languageDescription":"Polish"}]},{"id":264350,"number":2,"secondaryObjective":"CORE: To determine the safety of [CCI] mg, [CCI] mg, or [CCI] mg of BPL-003 given with psychological support to participants with TRD","secondaryObjectiveTranslations":[{"id":5895794,"uuid":"7a1e76c3-8208-4c2a-b443-8d8ad8541610","attributeTranslation":"CORE: Określenie bezpieczeństwa [CCI] mg, [CCI] mg lub [CCI] mg BPL-003 podawanego z jednoczesnym wsparciem psychologicznym uczestnikom z TRD","language":19,"languageDescription":"Polish"},{"id":5895795,"uuid":"7a1e76c3-8208-4c2a-b443-8d8ad8541610","attributeTranslation":"CORE: Determinar la seguridad de [CCI] mg, [CCI] mg o [CCI] mg de BPL-003 administrados con apoyo psicológico a participantes con DRT","language":7,"languageDescription":"Spanish"}]},{"id":264351,"number":3,"secondaryObjective":"CORE: To evaluate the pharmacokinetics (PK) of 5-methoxy-N,Ndimethyltryptamine (5-MeO-DMT) and its metabolites (including bufotenine) in participants with TRD after nasal administration of BPL- 003","secondaryObjectiveTranslations":[{"id":5895796,"uuid":"55103ff6-d98d-4bcb-8312-55240d8c0f79","attributeTranslation":"CORE: Ocena farmakokinetyki (PK) 5-metoksy-N,Ndimetylotryptaminy (5-MeO-DMT) i jej metabolitów (w tym bufoteniny) u uczestników z TRD po donosowym podaniu BPL-003","language":19,"languageDescription":"Polish"},{"id":5895797,"uuid":"55103ff6-d98d-4bcb-8312-55240d8c0f79","attributeTranslation":"CORE: Evaluar la farmacocinética (FC) de 5-metoxi-N,N-dimetiltriptamina (5-MeO-DMT) y sus metabolitos (incluida la bufotenina) en participantes con DRT tras la administración nasal de BPL-003","language":7,"languageDescription":"Spanish"}]},{"id":264352,"number":4,"secondaryObjective":"CORE: To determine the effects on depression and disability of [CCI] mg, [CCI] mg, or [CCI] mg of BPL-003 given with psychological support to participants with TRD","secondaryObjectiveTranslations":[{"id":5895799,"uuid":"04fd8fa4-a817-4197-b258-aca4d6e86def","attributeTranslation":"CORE: Ustalenie wpływu na depresję i niepełnosprawność dawek [CCI] mg, [CCI] mg lub [CCI] mg BPL-003 podawanych z jednoczesnym wsparciem psychologicznym uczestnikom z TRD","language":19,"languageDescription":"Polish"},{"id":5895798,"uuid":"04fd8fa4-a817-4197-b258-aca4d6e86def","attributeTranslation":"CORE: Determinar los efectos sobre la depresión y la discapacidad de [CCI] mg, [CCI] mg o [CCI] mg de BPL-003 administrados con apoyo psicológico a participantes con DRT","language":7,"languageDescription":"Spanish"}]},{"id":264353,"number":5,"secondaryObjective":"OLE: To determine the efficacy of [CCI] BPL-003 given with psychological support to participants with TRD","secondaryObjectiveTranslations":[{"id":5895801,"uuid":"e1a4c56f-364f-46b6-91fc-3408afadd342","attributeTranslation":"OLE: Determinar la eficacia de [CCI] BPL-003 administrada con apoyo psicológico a participantes con DRT","language":7,"languageDescription":"Spanish"},{"id":5895800,"uuid":"e1a4c56f-364f-46b6-91fc-3408afadd342","attributeTranslation":"OLE: Określenie skuteczności [CCI] BPL-003 podawanego z jednoczesnym wsparciem psychologicznym uczestnikom z TRD","language":19,"languageDescription":"Polish"}]},{"id":264354,"number":6,"secondaryObjective":"OLE: To evaluate the PK of 5-MeO-DMT and its metabolites (including bufotenine) in participants with TRD after nasal administration of BPL- 003","secondaryObjectiveTranslations":[{"id":5895803,"uuid":"0717d949-14d0-45ad-99b5-aa1aadd92791","attributeTranslation":"OLE: Ocena farmakokinetyki 5-MeO-DMT i jej metabolitów (w tym bufoteniny) u uczestników z TRD po donosowym podaniu BPL-003","language":19,"languageDescription":"Polish"},{"id":5895802,"uuid":"0717d949-14d0-45ad-99b5-aa1aadd92791","attributeTranslation":"OLE: Evaluar la FC de 5-MeO-DMT y sus metabolitos (incluida la bufotenina) en participantes con DRT tras la administración nasal de BPL-003","language":7,"languageDescription":"Spanish"}]},{"id":264355,"number":7,"secondaryObjective":"OLE: To determine the effects of [CCI] BPL-003 on depression & disability, given with psychological support to participants with TRD","secondaryObjectiveTranslations":[{"id":5895804,"uuid":"e300c0ee-1729-4c53-89b6-bf8c403e1b04","attributeTranslation":"OLE: Określenie wpływu [CCI] BPL-003 na depresję i niepełnosprawność, podawanego z jednoczesnym wsparciem psychologicznym uczestnikom z TRD","language":19,"languageDescription":"Polish"},{"id":5895805,"uuid":"e300c0ee-1729-4c53-89b6-bf8c403e1b04","attributeTranslation":"Determinar los efectos de [CCI] BPL-003 sobre la depresión y la discapacidad, administrada con apoyo psicológico a participantes con DRT","language":7,"languageDescription":"Spanish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":512588,"number":1,"principalInclusionCriteria":"1. Willing and able to give informed consent, with written informed consent available before any study assessments.","principalInclusionCriteriaTranslations":[{"id":5895758,"uuid":"e42f9753-dc67-4185-be6a-1191614b94e5","attributeTranslation":"1. Chęć i zdolność do wyrażenia świadomej zgody, przy czym przed dokonaniem jakichkolwiek ocen w badaniu konieczne jest uzyskanie świadomej zgody uczestnika na piśmie.","language":19,"languageDescription":"Polish"},{"id":5895757,"uuid":"e42f9753-dc67-4185-be6a-1191614b94e5","attributeTranslation":"1. Estar dispuesto y ser capaz de dar el consentimiento informado. El consentimiento informado por escrito debe encontrarse disponible antes de realizar ninguna evaluación del estudio.","language":7,"languageDescription":"Spanish"}]},{"id":512589,"number":10,"principalInclusionCriteria":"10. Willing to abstain from recreational drugs from Screening until the end of the study. • Intermittent use of cannabinoids prior to Screening is not exclusionary as long as the participant does not meet the criteria for substance use disorder, as assessed using the DSM-5.","principalInclusionCriteriaTranslations":[{"id":5895760,"uuid":"8ee558d1-03e1-4ef4-988b-6c7571dc9192","attributeTranslation":"10. Estar dispuesto a abstenerse de las drogas desde la selección hasta el final del estudio.\n• El uso intermitente de cannabinoides antes de la selección no es excluyente, siempre que el participante no cumpla con los criterios de trastornos relacionados con el consumo de sustancias, según lo evaluado mediante el DSM-5.","language":7,"languageDescription":"Spanish"},{"id":5895759,"uuid":"8ee558d1-03e1-4ef4-988b-6c7571dc9192","attributeTranslation":"10. Chęć do powstrzymania się od narkotyków rekreacyjnych począwszy od badania przesiewowego do końca badania.\n Przerywane używanie kannabinoidów przed badaniem przesiewowym nie stanowi kryterium wykluczającego, o ile uczestnik nie spełnia kryteriów zaburzenia związanego z używaniem substancji, zgodnie z oceną za pomocą DSM-5.","language":19,"languageDescription":"Polish"}]},{"id":512590,"number":11,"principalInclusionCriteria":"11. Willing to allow their own general practitioner, and consultant if appropriate, to be informed of study participation.","principalInclusionCriteriaTranslations":[{"id":5895762,"uuid":"96ecbb95-bd38-496d-b191-552da7bdac5d","attributeTranslation":"11. Uczestnik umożliwia poinformowanie o swoim udziale w badaniu lekarza pierwszego kontaktu i konsultanta, jeśli jest to właściwe.","language":19,"languageDescription":"Polish"},{"id":5895761,"uuid":"96ecbb95-bd38-496d-b191-552da7bdac5d","attributeTranslation":"11. Estar dispuesto a permitir que su propio médico general y psicoterapeuta, si corresponde, sean informados sobre la participación en el estudio.","language":7,"languageDescription":"Spanish"}]},{"id":512591,"number":12,"principalInclusionCriteria":"OLE: 1. Participants who complete the CORE study.","principalInclusionCriteriaTranslations":[{"id":5895764,"uuid":"02423a17-daae-4e28-8efb-e679202c6e39","attributeTranslation":"OLE: 1. Participantes que completen el estudio CORE.","language":7,"languageDescription":"Spanish"},{"id":5895763,"uuid":"02423a17-daae-4e28-8efb-e679202c6e39","attributeTranslation":"OLE: 1. Uczestnicy, którzy ukończyli BADANIE GŁÓWNE.","language":19,"languageDescription":"Polish"}]},{"id":512592,"number":13,"principalInclusionCriteria":"OLE: 2. Willing and able to give informed consent for the OLE.","principalInclusionCriteriaTranslations":[{"id":5895766,"uuid":"56b0a6d6-83e4-4df6-9a9d-ec555c91f0a5","attributeTranslation":"OLE: 2. Chęć i możliwość wyrażenia świadomej zgody na OLE.","language":19,"languageDescription":"Polish"},{"id":5895765,"uuid":"56b0a6d6-83e4-4df6-9a9d-ec555c91f0a5","attributeTranslation":"OLE: 2. Estar dispuesto y ser capaz de dar el consentimiento informado para la OLE.","language":7,"languageDescription":"Spanish"}]},{"id":512593,"number":14,"principalInclusionCriteria":"OLE: 3. Willing to abstain from alcohol for 48 hours before OLE [CCI].","principalInclusionCriteriaTranslations":[{"id":5895768,"uuid":"84e05201-00e0-4bbc-8377-40ae9619a1e0","attributeTranslation":"OLE: 3. Estar dispuesto a abstenerse del alcohol durante 48 horas antes del [CCI] de la OLE.","language":7,"languageDescription":"Spanish"},{"id":5895767,"uuid":"84e05201-00e0-4bbc-8377-40ae9619a1e0","attributeTranslation":"OLE: 3. Chęć powstrzymania się od alkoholu przez 48 godzin przed [CCI]. OLE.","language":19,"languageDescription":"Polish"}]},{"id":512594,"number":15,"principalInclusionCriteria":"OLE: 4. Willing to abstain from recreational drugs throughout the duration of the study.","principalInclusionCriteriaTranslations":[{"id":5895769,"uuid":"1bf614af-66a4-4dba-9583-d7ad4e41c293","attributeTranslation":"OLE: 4. Chęć powstrzymania się od narkotyków rekreacyjnych przez cały czas trwania badania.","language":19,"languageDescription":"Polish"},{"id":5895770,"uuid":"1bf614af-66a4-4dba-9583-d7ad4e41c293","attributeTranslation":"OLE: 4. Estar dispuesto a abstenerse de las drogas a lo largo de todo el estudio.","language":7,"languageDescription":"Spanish"}]},{"id":512595,"number":2,"principalInclusionCriteria":"2. Male and female participants, age 18 to 75 years at the time of informed consent.","principalInclusionCriteriaTranslations":[{"id":5895771,"uuid":"c145236e-73c4-4059-aa9f-de8417f69cfa","attributeTranslation":"2. Hombres y mujeres de 18 a 75 años en el momento del consentimiento informado.","language":7,"languageDescription":"Spanish"},{"id":5895772,"uuid":"c145236e-73c4-4059-aa9f-de8417f69cfa","attributeTranslation":"2. Uczestnicy płci męskiej i żeńskiej, w wieku od 18 do 75 lat w momencie wyrażenia świadomej zgody.","language":19,"languageDescription":"Polish"}]},{"id":512596,"number":3,"principalInclusionCriteria":"3. At least moderate major depressive disorder (MDD), (single or recurrent episode as informed by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria; if single episode, duration of ≥3 months and ≤ 2 years) based on medical records, clinical assessment, and documented completion of the version 7.0.2 Mini International Neuropsychiatric Interview (MINI). For clarification, if recurrent MDD, there is no limit on episode duration.","principalInclusionCriteriaTranslations":[{"id":5895773,"uuid":"10e967ad-9a06-42e2-9ba9-9ca33cadc211","attributeTranslation":"3. Trastorno depresivo mayor (TDM) al menos moderado (episodio único o recurrente según los criterios del Manual diagnóstico y estadístico de los trastornos mentales, quinta edición [DSM-5]; si es un episodio único, duración de ≥3 meses y ≤2 años) basado en la historia clínica, la evaluación clínica y la cumplimentación documentada de la versión 7.0.2 de la Entrevista Neuropsiquiátrica Internacional Reducida (Mini International Neuropsychiatric Interview, MINI).\nComo aclaración, si es un TDM recurrente, no hay límite en la duración del episodio.","language":7,"languageDescription":"Spanish"},{"id":5895774,"uuid":"10e967ad-9a06-42e2-9ba9-9ca33cadc211","attributeTranslation":"3. Depresja duża (MDD) o nasileniu co najmniej umiarkowanym (pojedynczy lub nawracający epizod, zgodnie z kryteriami zawartymi w podręczniku Kryteria diagnostyczne zaburzeń psychicznych (Diagnostic and Statistical Manual of Mental Disorders) wydanie 5 [DSM-5]; jeśli pojedynczy epizod trwa ≥3 miesiące i ≤2 lata) na podstawie dokumentacji medycznej, oceny klinicznej i udokumentowanego wypełnienia wersji 7.0.2 międzynarodowego wywiadu neuropsychiatrycznego (Mini International Neuropsychiatric Interview, MINI).\nDla wyjaśnienia –, w przypadku nawrotowej MDD nie określono limitu czasu trwania epizodu.","language":19,"languageDescription":"Polish"}]},{"id":512597,"number":4,"principalInclusionCriteria":"4. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments, in the current episode, based on the MGH ATRQ assessment. Augmentation with an add-on treatment counts as a second treatment. Participants must not have failed more than 5 prior pharmacological treatments current episode (psychotherapy is not counted towards treatment failure). For clarification, pharmacological treatments initially effective but subsequently ineffective (tachyphylaxis) will be considered treatment failures if they fulfil the ATRQ criteria for dose and duration of failure.","principalInclusionCriteriaTranslations":[{"id":5895776,"uuid":"e41aa8b5-d3f5-4ea9-af26-8787e0f4bd3e","attributeTranslation":"4. Zdiagnozowana TRD, która została zdefiniowana jako brak odpowiedzi na odpowiednią dawkę i trwająca co najmniej 2 terapie farmakologiczne, podczas obecnego epizodu, na podstawie oceny MGH ATRQ. Wzmocnienie efektu leczeniem dodatkowym liczy się jako drugie leczenie. U uczestników nie mogło nastąpić więcej niż 5 wcześniejszych przypadków niepowodzenia leczenia farmakologicznego w bieżącym epizodzie (psychoterapia nie jest liczona jako niepowodzenie leczenia).\nDla wyjaśnienia –, leczenie farmakologiczne, które początkowo było skuteczne, ale następnie utraciło skuteczność (wystąpiła tachyfilaksja), zostanie uznane za niepowodzenie leczenia, jeśli spełni kryteria ATRQ dotyczące dawki i czasu trwania braku skuteczności.","language":19,"languageDescription":"Polish"},{"id":5895775,"uuid":"e41aa8b5-d3f5-4ea9-af26-8787e0f4bd3e","attributeTranslation":"4. Diagnóstico de DRT, definida como la falta de respuesta a una dosis adecuada y duración de al menos 2 tratamientos farmacológicos, en el episodio actual, según el cuestionario ATRQ del MGH. El refuerzo con un tratamiento suplementario cuenta como segundo tratamiento. Los participantes no deben haber presentado fracasos terapéuticos en más de 5 tratamientos farmacológicos previos en el episodio actual (la psicoterapia no cuenta para los fracasos terapéuticos).\nA modo de aclaración, los tratamientos farmacológicos que inicialmente son eficaces pero que luego pierden su eficacia (taquifilaxia) se considerarán fracasos del tratamiento si cumplen con los criterios ATRQ en cuanto a dosis y duración.","language":7,"languageDescription":"Spanish"}]},{"id":512598,"number":5,"principalInclusionCriteria":"5. Hamilton Depression Rating Scale (HDRS) (17 item) score ≥19 at Screening (Visit 1) and baseline (Day -3).","principalInclusionCriteriaTranslations":[{"id":5895778,"uuid":"ad7ba757-320e-4a06-b49f-284d5c7aef2b","attributeTranslation":"5. Wynik w skali depresji Hamiltona (Hamilton Depression Rating Scale, HDRS) (17 pozycji) ≥19 podczas badania przesiewowego (Wizyta 1) i w punkcie początkowym (Dzień -3).","language":19,"languageDescription":"Polish"},{"id":5895777,"uuid":"ad7ba757-320e-4a06-b49f-284d5c7aef2b","attributeTranslation":"5. Puntuación de la escala de evaluación de la depresión de Hamilton (Hamilton Depression Rating Scale, HDRS) (17 ítems) ≥19 en la selección (visita 1) y al inicio (día −3).","language":7,"languageDescription":"Spanish"}]},{"id":512599,"number":6,"principalInclusionCriteria":"6. CGI-S ≥4 at Screening and baseline (Day -3).","principalInclusionCriteriaTranslations":[{"id":5895780,"uuid":"98ec8b97-3daf-45eb-9b0c-a1a6f298c638","attributeTranslation":"6. CGI-S ≥4 en la selección y al inicio (día −3).","language":7,"languageDescription":"Spanish"},{"id":5895779,"uuid":"98ec8b97-3daf-45eb-9b0c-a1a6f298c638","attributeTranslation":"6. CGI-S ≥4 w badaniu przesiewowym i w punkcie początkowym (Dzień -3).","language":19,"languageDescription":"Polish"}]},{"id":512600,"number":7,"principalInclusionCriteria":"7. If currently taking antidepressant medications, willing and able to discontinue current antidepressants including selective serotonin reuptake inhibitor, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, and any augmentation medication such as antipsychotics or lithium. Withdrawal will follow local treatment guidelines and should aim to avoid withdrawal symptoms by gradually reducing the antidepressant treatment dose.","principalInclusionCriteriaTranslations":[{"id":5895782,"uuid":"af17a29f-53e6-44b1-9970-de4780f7bb2f","attributeTranslation":"7. Jeśli obecnie przyjmuje leki przeciwdepresyjne, chce i może odstawić obecne leki przeciwdepresyjne, w tym selektywne inhibitory wychwytu zwrotnego serotoniny, inhibitory wychwytu zwrotnego serotoniny i noradrenaliny, trójpierścieniowe leki przeciwdepresyjne, inhibitory monoaminooksydazy oraz wszelkie leki wzmacniające, takie jak leki przeciwpsychotyczne lub lit. Odstawienie leczenia zostanie przeprowadzone zgodnie z lokalnie obowiązującymi wytycznymi i powinno ono mieć na celu uniknięcie wystąpienia objawów odstawienia przez stopniowe zmniejszanie dawki leku przeciwdepresyjnego","language":19,"languageDescription":"Polish"},{"id":5895781,"uuid":"af17a29f-53e6-44b1-9970-de4780f7bb2f","attributeTranslation":"7. Si actualmente toma medicamentos antidepresivos; estar dispuesto y ser capaz de suspender los antidepresivos actuales, incluidos los inhibidores selectivos de la recaptación de serotonina, los inhibidores de la recaptación de serotonina y norepinefrina, los antidepresivos tricíclicos, los inhibidores de la monoaminooxidasa y cualquier medicamento de refuerzo, como los antipsicóticos o el litio. La suspensión seguirá las directrices locales de tratamiento y debe tratar de evitar la aparición de síntomas de abstinencia mediante una reducción gradual de la dosis terapéutica de los antidepresivos.","language":7,"languageDescription":"Spanish"}]},{"id":512601,"number":8,"principalInclusionCriteria":"8. Able (in the investigator's opinion) and willing to undertake and comply with all study requirements, including ability to complete all protocol required assessment tools and to comply with all study visits in language used by study site.","principalInclusionCriteriaTranslations":[{"id":5895784,"uuid":"ac63f2d6-aab8-41bc-9bd9-c8f935c2ec17","attributeTranslation":"8. Estar dispuesto y ser capaz (en opinión del investigador) de emprender y cumplir con todos los requisitos del estudio, incluida la capacidad de completar todas las herramientas de evaluación requeridas por el protocolo y cumplir con todas las visitas del estudio en el idioma utilizado por el centro del estudio.","language":7,"languageDescription":"Spanish"},{"id":5895783,"uuid":"ac63f2d6-aab8-41bc-9bd9-c8f935c2ec17","attributeTranslation":"8. Uczestnik zdolny (w opinii badacza) i chętny do podjęcia, i spełnienia wszystkich wymagań badania, w tym do wypełnienia wszystkich narzędzi do oceny wymaganych w protokole oraz do przestrzegania wszystkich wizyt w ramach badania w języku używanym w ośrodku badawczym.","language":19,"languageDescription":"Polish"}]},{"id":512602,"number":9,"principalInclusionCriteria":"9. Willing to abstain from alcohol for 48 hours before [CCI].","principalInclusionCriteriaTranslations":[{"id":5895785,"uuid":"de341775-b865-4de5-8a31-d7740190dc35","attributeTranslation":"9. Estar dispuesto a abstenerse del alcohol durante 48 horas antes del [CCI].","language":7,"languageDescription":"Spanish"},{"id":5895786,"uuid":"de341775-b865-4de5-8a31-d7740190dc35","attributeTranslation":"9. Chęć do powstrzymania się od alkoholu przez 48 godzin przed [CCI].","language":19,"languageDescription":"Polish"}]}],"principalExclusionCriteria":[{"id":883069,"number":1,"principalExclusionCriteria":"1. Use of cannabinoids is not allowed for the duration of the study. Participants should not be administered the study drug if they have a positive urine drug screen result for cannabinoids pre-dose on [CCI] (retesting is allowed if there is a suspected false positive test).","principalExclusionCriteriaTranslations":[{"id":5895719,"uuid":"816c4d52-2d9d-46d1-bdd5-336cec8fb30e","attributeTranslation":"1. Stosowanie kannabinoidów jest niedozwolone przez cały czas trwania badania. Uczestnikom nie należy podawać badanego leku w przypadku dodatniego wyniku badania przesiewowego moczu na obecność kannabinoidów przed podaniem dawki w [CCI]. (powtórzenie badania jest dozwolone, jeśli istnieje podejrzenie fałszywie dodatniego wyniku).","language":19,"languageDescription":"Polish"},{"id":5895718,"uuid":"816c4d52-2d9d-46d1-bdd5-336cec8fb30e","attributeTranslation":"1. No está permitido el uso de canabinoides a lo largo de todo el estudio. A los participantes no se les debe administrar el fármaco del estudio si tienen una prueba de drogas en orina positiva para canabinoides antes de la dosis del [CCI] (se permite repetir la prueba si hay sospecha de falso positivo).","language":7,"languageDescription":"Spanish"}]},{"id":883070,"number":10,"principalExclusionCriteria":"10. Depression is secondary to other severe medical conditions according to the investigator's opinion.","principalExclusionCriteriaTranslations":[{"id":5895721,"uuid":"cf598d87-1e86-430f-94e8-71b54d68dfc1","attributeTranslation":"10. Według opinii badacza depresja jest wtórna do innych ciężkich schorzeń.","language":19,"languageDescription":"Polish"},{"id":5895720,"uuid":"cf598d87-1e86-430f-94e8-71b54d68dfc1","attributeTranslation":"10. Depresión que sea secundaria a otras enfermedades graves según la opinión del investigador.","language":7,"languageDescription":"Spanish"}]},{"id":883071,"number":11,"principalExclusionCriteria":"11. Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to the study medication.","principalExclusionCriteriaTranslations":[{"id":5895722,"uuid":"1ba2d35f-311b-4dcf-abdb-5ee2a2dc5e13","attributeTranslation":"11. Otras circunstancias personales y conductas que se consideren incompatibles con el establecimiento de una relación o exposición segura al medicamento del estudio.","language":7,"languageDescription":"Spanish"},{"id":5895723,"uuid":"1ba2d35f-311b-4dcf-abdb-5ee2a2dc5e13","attributeTranslation":"11. Inne osobiste okoliczności i zachowania uznane za niezgodne z nawiązaniem kontaktu lub bezpieczną ekspozycją na badany lek.","language":19,"languageDescription":"Polish"}]},{"id":883072,"number":12,"principalExclusionCriteria":"12. Any other clinically significant psychiatric condition that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study.","principalExclusionCriteriaTranslations":[{"id":5895725,"uuid":"761d1c66-fe95-4e04-86d5-093bb14edafb","attributeTranslation":"12. Każdy inny klinicznie istotny stan psychiczny, który w opinii badacza może zakłócać interpretację wyników badania lub stanowić zagrożenie dla zdrowia uczestnika, jeśli uczestnik/uczestniczka weźmie udział w badaniu.","language":19,"languageDescription":"Polish"},{"id":5895724,"uuid":"761d1c66-fe95-4e04-86d5-093bb14edafb","attributeTranslation":"12. Cualquier otra enfermedad psiquiátrica clínicamente significativa que, en opinión del investigador, pueda interferir en la interpretación de los resultados del estudio o constituir un riesgo para la salud del participante si participa en el estudio.","language":7,"languageDescription":"Spanish"}]},{"id":883073,"number":13,"principalExclusionCriteria":"OLE: 1. Currently taking antidepressant medication.","principalExclusionCriteriaTranslations":[{"id":5895727,"uuid":"b2c35a40-b81a-4d6e-a89b-97b1a446399d","attributeTranslation":"OLE: 1. Obecnie przyjmuje leki przeciwdepresyjne.","language":19,"languageDescription":"Polish"},{"id":5895726,"uuid":"b2c35a40-b81a-4d6e-a89b-97b1a446399d","attributeTranslation":"OLE: 1. Tomar actualmente medicamentos antidepresivos.","language":7,"languageDescription":"Spanish"}]},{"id":883074,"number":14,"principalExclusionCriteria":"OLE: 2. Currently taking any other prohibited medication.","principalExclusionCriteriaTranslations":[{"id":5895728,"uuid":"048c5ab3-eb24-4fd5-b953-78a64a3a829f","attributeTranslation":"OLE: 2. Tomar actualmente cualquier otro medicamento prohibido.","language":7,"languageDescription":"Spanish"},{"id":5895729,"uuid":"048c5ab3-eb24-4fd5-b953-78a64a3a829f","attributeTranslation":"OLE: 2. Obecnie przyjmuje jakiekolwiek inne niedozwolone leki.","language":19,"languageDescription":"Polish"}]},{"id":883075,"number":15,"principalExclusionCriteria":"OLE: 3. Participants who, in the opinion of the investigator, are not suitable to participate in the OLE.","principalExclusionCriteriaTranslations":[{"id":5895731,"uuid":"c10cb689-9451-4f42-9454-508a2a193ba5","attributeTranslation":"OLE: 3. Uczestnicy, którzy w opinii badacza nie kwalifikują się do udziału w OLE.","language":19,"languageDescription":"Polish"},{"id":5895730,"uuid":"c10cb689-9451-4f42-9454-508a2a193ba5","attributeTranslation":"OLE: 3. Participantes que, a juicio del investigador, no sean aptos para participar en la OLE.","language":7,"languageDescription":"Spanish"}]},{"id":883076,"number":16,"principalExclusionCriteria":"OLE: 4. Participants who met the Subject Dosing Stopping Criteria in the CORE","principalExclusionCriteriaTranslations":[{"id":5895733,"uuid":"f87b3c7f-3763-486f-886c-dda267f810ab","attributeTranslation":"OLE: 4. Uczestnicy spełniający kryteria zakończenia podawania leku w BADANIU GŁÓWNYM.","language":19,"languageDescription":"Polish"},{"id":5895732,"uuid":"f87b3c7f-3763-486f-886c-dda267f810ab","attributeTranslation":"OLE: 4. Participantes que han cumplido los criterios de parada de la administración de dosis en el/la sujeto en el CORE.","language":7,"languageDescription":"Spanish"}]},{"id":883077,"number":17,"principalExclusionCriteria":"OLE: 5. Participants with controlled hypertension on antihypertensive therapy are excluded if repeated clinic seated or semi-recumbent systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥ 80 mmHg. Participants without a diagnosis of hypertension are excluded if repeated clinic seated or semi-recumbent systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg. Blood pressure eligibility should be assessed during Screening and predose on [CCI].","principalExclusionCriteriaTranslations":[{"id":5895735,"uuid":"59dacf89-b2ba-4ff4-93db-27a5cbf6c638","attributeTranslation":"OLE: 5. Uczestnicy z kontrolowanym nadciśnieniem lub stosujący leczenie przeciwnadciśnieniowe są wykluczeni, jeżeli podczas powtarzanych pomiarów w poradni w pozycji siedzącej lub półleżącej skurczowe ciśnienie krwi wynosi ≥130 mmHg lub rozkurczowe ciśnienie krwi ≥80 mmHg. Uczestnicy bez rozpoznanego nadciśnienia są wykluczeni, jeżeli podczas powtarzanych pomiarów w poradni w pozycji siedzącej lub półleżącej skurczowe ciśnienie krwi wynosi ≥140 mmHg lub rozkurczowe ciśnienie krwi ≥90 mmHg. Spełnianie kryteriów kwalifikacyjnych odnoszących się do ciśnienia krwi należy poddać ocenie w okresie przesiewowym i przed podaniem dawki w [CCI].","language":19,"languageDescription":"Polish"},{"id":5895734,"uuid":"59dacf89-b2ba-4ff4-93db-27a5cbf6c638","attributeTranslation":"OLE: 5. Los participantes con hipertensión controlada que reciben tratamiento antihipertensivo se excluyen si la presión arterial sistólica en sedestación o levemente recostado/a es ≥130 mmHg o la presión arterial diastólica es ≥80 mmHg de repetición. Los participantes sin un diagnóstico de hipertensión se excluyen si la presión arterial sistólica en sedestación o levemente recostado/a es ≥140 mmHg o la presión arterial diastólica es ≥90 mmHg de repetición. Debe evaluarse la elegibilidad de la presión arterial durante la selección y la dosis previa en el [CCI].","language":7,"languageDescription":"Spanish"}]},{"id":883078,"number":18,"principalExclusionCriteria":"OLE: 6. Participants where the CORE dose was not well tolerated.","principalExclusionCriteriaTranslations":[{"id":5895737,"uuid":"67fc890c-536e-464b-8b5f-fa207136196b","attributeTranslation":"OLE: 6. Participantes en los que no fue bien tolerada la dosis de CORE.","language":7,"languageDescription":"Spanish"},{"id":5895736,"uuid":"67fc890c-536e-464b-8b5f-fa207136196b","attributeTranslation":"OLE: 6. Uczestnicy, u których dawka stosowana w BADANIU GŁÓWNYM nie była dobrze tolerowana.","language":19,"languageDescription":"Polish"}]},{"id":883079,"number":2,"principalExclusionCriteria":"2. Current or past history of schizophrenia, post-traumatic stress disorder, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder as assessed by medical history and a structured clinical interview (MINI).","principalExclusionCriteriaTranslations":[{"id":5895739,"uuid":"7f465bd7-be31-4806-84de-d8a9e0d8d4df","attributeTranslation":"2. Obecna lub stwierdzona w wywiadzie schizofrenia, zespół stresu pourazowego, zaburzenia psychotyczne, w tym depresja psychotyczna, choroba afektywna dwubiegunowa, zaburzenia urojeniowe, zaburzenia schizoafektywne lub inne ciężkie zaburzenia psychiczne, oceniane na podstawie wywiadu medycznego i ustrukturyzowanego wywiadu klinicznego (MINI).","language":19,"languageDescription":"Polish"},{"id":5895738,"uuid":"7f465bd7-be31-4806-84de-d8a9e0d8d4df","attributeTranslation":"2. Episodios actuales o antecedentes de esquizofrenia, trastorno de estrés post-traumático, trastorno psicótico que incluye depresión psicótica, trastorno bipolar, trastorno delirante, trastorno esquizoafectivo o cualquier otro trastorno psiquiátrico grave según lo evaluado por la anamnesis y una entrevista clínica estructurada (MINI).","language":7,"languageDescription":"Spanish"}]},{"id":883080,"number":3,"principalExclusionCriteria":"3. Current personality disorders: Cluster A (paranoid, schizoid, schizotypal), Cluster B (antisocial, borderline, histrionic, narcissistic), or Cluster C (avoidant, dependent, -obsessive compulsive) assessed via McLean Screening Instrument for Borderline Personality Disorder (MSIBPD), MINI, and clinical judgement.","principalExclusionCriteriaTranslations":[{"id":5895740,"uuid":"23a68364-5c91-4583-89b9-76d9e8d060f9","attributeTranslation":"3. Trastornos de personalidad actuales: grupo A (paranoide, esquizoide, esquizotípico), grupo B (antisocial, límite, histriónico, narcisista) o grupo C (evitativo, dependiente, obsesivo-compulsivo), evaluados a través del instrumento de cribado de McLean para el trastorno límite de la personalidad (McLean Screening Instrument for Borderline Personality Disorder, MSI- BPD), la MINI y el razonamiento clínico.","language":7,"languageDescription":"Spanish"},{"id":5895741,"uuid":"23a68364-5c91-4583-89b9-76d9e8d060f9","attributeTranslation":"3. Obecne zaburzenia osobowości: typu A (paranoidalne, schizoidalne, schizotypowe), typu B (antyspołeczne, borderline, histrioniczne, narcystyczne) lub typu C (unikające, zależne, obsesyjno-kompulsywne) oceniane za pomocą narzędzia McLean'a do przesiewowego badania zaburzeń osobowości typu borderline (Screening Instrument for Borderline Personality Disorder, MSI- BPD), MINI i oceny klinicznej.","language":19,"languageDescription":"Polish"}]},{"id":883081,"number":4,"principalExclusionCriteria":"4. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.","principalExclusionCriteriaTranslations":[{"id":5895742,"uuid":"fc8f2c34-b326-4f97-94c8-94ff74a21c9d","attributeTranslation":"4. Schizofrenia, choroba afektywna dwubiegunowa, zaburzenie urojeniowe lub zaburzenie schizoafektywne w wywiadzie rodzinnym krewnych pierwszego stopnia.","language":19,"languageDescription":"Polish"},{"id":5895743,"uuid":"fc8f2c34-b326-4f97-94c8-94ff74a21c9d","attributeTranslation":"4. Antecedentes familiares de primer grado de esquizofrenia, trastorno bipolar, trastorno delirante o trastorno esquizoafectivo.","language":7,"languageDescription":"Spanish"}]},{"id":883082,"number":5,"principalExclusionCriteria":"5. Current (within the last year) alcohol or substance use disorder (other than caffeine or nicotine) according to DSM-5 and assessed by the MINI at Screening that in the opinion of the investigator will be a safety concern for enrollment in the study or that could interfere with the therapeutic process or with other aspects of study participation. Any participant who is not able to agree or adhere to a plan to reduce and manage use will be excluded.","principalExclusionCriteriaTranslations":[{"id":5895745,"uuid":"8977f24e-5568-4004-8607-9a52e32db1bb","attributeTranslation":"5. Trastorno actual (en el último año) por consumo de alcohol o de sustancias (que no sean cafeína o nicotina) según el DSM-5 y evaluado por la MINI en la selección, y que según la opinión del/de la investigador/a es un problema de seguridad para la inclusión en el estudio o que puede interferir en el proceso terapéutico o en otros aspectos de la participación en el estudio. Se excluirá a los participantes que no acepten seguir un plan para reducir y controlar el consumo, o no puedan cumplirlo.","language":7,"languageDescription":"Spanish"},{"id":5895744,"uuid":"8977f24e-5568-4004-8607-9a52e32db1bb","attributeTranslation":"5. Obecne (w ciągu ostatniego roku) zaburzenie związane z używaniem alkoholu lub substancji (innych niż kofeina lub nikotyna) zgodnie z DSM-5 i ocenione przez MINI podczas badania przesiewowego, tak że w opinii badacza stanowi to zagrożenie dla bezpieczeństwa przy włączeniu do badania lub może zakłócać proces terapeutyczny lub inne aspekty udziału w badaniu. Każdy uczestnik, który nie jest w stanie wyrazić zgody na przedstawiony plan odnośnie ograniczenia i kontrolowania lub nie jest w stanie go przestrzegać, zostanie wykluczony.","language":19,"languageDescription":"Polish"}]},{"id":883083,"number":6,"principalExclusionCriteria":"6. A participant who at any time has been unresponsive to ketamine or esketamine, unresponsive to an adequate course of treatment with electroconvulsive therapy (ECT) defined as at least 7 treatments with unilateral/bilateral ECT, or has received vagal nerve stimulation or has received deep brain stimulation.","principalExclusionCriteriaTranslations":[{"id":5895746,"uuid":"baebc69e-c984-4bcb-a2c4-5556987c985b","attributeTranslation":"6. Participantes que, en algún momento, no hayan respondido a la ketamina o a la esketamina; no hayan respondido a una tanda adecuada de tratamiento con terapia electroconvulsiva (TEC), definida como al menos 7 tratamientos con TEC unilateral/bilateral; hayan recibido estimulación del nervio vago; o hayan recibido estimulación cerebral profunda.","language":7,"languageDescription":"Spanish"},{"id":5895747,"uuid":"baebc69e-c984-4bcb-a2c4-5556987c985b","attributeTranslation":"6. Uczestnik, który w jakimkolwiek momencie nie reagował na ketaminę lub esketaminę, nie reagował na odpowiedni cykl leczenia terapią elektrowstrząsową (electroconvulsive therapy, EW), zdefiniowany jako co najmniej 7 zabiegów z jednostronną/obustronną terapią elektrowstrząsową (ECT) lub otrzymał stymulację nerwu błędnego lub otrzymał głęboką stymulację mózgu.","language":19,"languageDescription":"Polish"}]},{"id":883084,"number":7,"principalExclusionCriteria":"7. Currently receiving prohibited medications or therapy.","principalExclusionCriteriaTranslations":[{"id":5895749,"uuid":"c13f2bef-a219-41e8-a246-78d5e4b7d55c","attributeTranslation":"7. Participantes que actualmente reciban medicamentos o tratamientos prohibidos","language":7,"languageDescription":"Spanish"},{"id":5895748,"uuid":"c13f2bef-a219-41e8-a246-78d5e4b7d55c","attributeTranslation":"7. Obecnie przyjmuje niedozwolone leki lub terapię","language":19,"languageDescription":"Polish"}]},{"id":883085,"number":8,"principalExclusionCriteria":"8. Suicidal ideation with some intent to act within 12 months prior to the start of Screening, per the investigator's clinical judgement or based on the C-SSRS, corresponding to a response of \"Yes\" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or any suicidal behavior within the 12 months prior to the start of Screening. Participants reporting suicidal ideation with intent to act or suicidal behavior as assessed on [CCI] should be excluded.","principalExclusionCriteriaTranslations":[{"id":5895750,"uuid":"4ada34d5-ce4b-4f88-b1ae-9eea318f4b55","attributeTranslation":"8. Ideas de suicidio con alguna intención de actuar en los 12 meses anteriores al inicio de la selección, según el razonamiento clínico del investigador o con base en la escala C-SSRS, correspondiente a una respuesta de \"Sí\" en el ítem 4 (ideas activas de suicidio con alguna intención de actuar, sin plan específico) o en el ítem 5 (ideas activas de suicidio con intención y plan específico) en relación con las ideas de suicidio en la C‑SSRS, o cualquier comportamiento suicida en los 12 meses anteriores al inicio de la selección. Los participantes que notifiquen ideas de suicidio con intención de actuar o comportamiento suicida según lo evaluado el [CCI] deben ser excluidos.","language":7,"languageDescription":"Spanish"},{"id":5895751,"uuid":"4ada34d5-ce4b-4f88-b1ae-9eea318f4b55","attributeTranslation":"8. Myśli samobójcze z pewnym zamiarem działania w ciągu 12 miesięcy przed rozpoczęciem badania przesiewowego, zgodnie z oceną kliniczną badacza lub na podstawie C-SSRS, odpowiadające odpowiedzi „Tak” w pozycji 4 (aktywne myśli samobójcze z pewnym zamiarem działania, bez konkretnego planu) lub pozycji 5 (aktywne myśli samobójcze z określonym planem i zamiarem) dla myśli samobójczych na C-SSRS lub jakiegokolwiek zachowania samobójczego w ciągu 12 miesięcy przed rozpoczęciem badań przesiewowych. Uczestnicy zgłaszający myśli samobójcze z zamiarem działania lub zachowania samobójcze ocenione w [CCI]. powinni zostać wykluczeni.","language":19,"languageDescription":"Polish"}]},{"id":883086,"number":9,"principalExclusionCriteria":"9. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.","principalExclusionCriteriaTranslations":[{"id":5895752,"uuid":"aa48d149-4e44-4c21-a797-f42dc043e180","attributeTranslation":"9. Próba samobójcza i/lub samookaleczenia w ciągu ostatnich 12 miesięcy przed badaniem przesiewowym.","language":19,"languageDescription":"Polish"},{"id":5895753,"uuid":"aa48d149-4e44-4c21-a797-f42dc043e180","attributeTranslation":"9. Intento de suicidio y/o conducta autolesiva en los 12 meses anteriores a la selección.","language":7,"languageDescription":"Spanish"}]}]},"endPoint":{"primaryEndPoints":[{"id":596970,"number":1,"endPoint":"CORE: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) for [CCI] mg compared to [CCI] mg of BPL-003 at [CCI]","isPrimary":true,"endPointTranslations":[{"id":5895656,"uuid":"c185e010-66e9-4e1b-a81d-50e8f14726d1","attributeTranslation":"CORE: Cambio desde el inicio en la escala de valoración de la depresión de Montgomery-Asberg (Montgomery-Asberg Depression Rating Scale, MADRS) con [CCI] mg en comparación con [CCI] mg de BPL-003 en [CCI]","language":7,"languageDescription":"Spanish"},{"id":5895657,"uuid":"c185e010-66e9-4e1b-a81d-50e8f14726d1","attributeTranslation":"CORE: Zmiana od punktu początkowego w skali oceny depresji Montgomery-Asberg (Montgomery-Asberg Depression Rating Scale, MADRS) dla dawki [CCI] mg w porównaniu z [CCI] mg BPL-003 w [CCI]","language":19,"languageDescription":"Polish"}]},{"id":596971,"number":2,"endPoint":"OLE: • Number of events and percentage of participants with TEAEs","isPrimary":true,"endPointTranslations":[{"id":5895658,"uuid":"c85f4599-c5ee-4bb7-8b51-56b17fe970c1","attributeTranslation":"OLE:  Liczba zdarzeń i odsetek uczestników z TEAE","language":19,"languageDescription":"Polish"},{"id":5895659,"uuid":"c85f4599-c5ee-4bb7-8b51-56b17fe970c1","attributeTranslation":"OLE: • Número de acontecimientos y porcentaje de participantes con AADT","language":7,"languageDescription":"Spanish"}]},{"id":596972,"number":3,"endPoint":"OLE: • Percentage of participants with clinically significant abnormal laboratory tests compared to OLE and CORE baseline","isPrimary":true,"endPointTranslations":[{"id":5895661,"uuid":"60a759fc-ed53-40fd-bb1a-a9a733ed1430","attributeTranslation":"OLE:  Odsetek uczestników z klinicznie istotnymi nieprawidłowymi wynikami badań laboratoryjnych w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"},{"id":5895660,"uuid":"60a759fc-ed53-40fd-bb1a-a9a733ed1430","attributeTranslation":"OLE: • Porcentaje de participantes con resultados anómalos de pruebas analíticas clínicamente significativos en comparación con el inicio del estudio principal (CORE) y la extensión sin enmascaramiento (OLE) del estudio","language":7,"languageDescription":"Spanish"}]},{"id":596973,"number":4,"endPoint":"OLE: • Percentage of participants with clinically significant abnormal vital sign measurements (heart rate, blood pressure, and body temperature) compared to OLE and CORE baseline","isPrimary":true,"endPointTranslations":[{"id":5895663,"uuid":"22ad3581-311e-4067-a510-82b3859ba48d","attributeTranslation":"OLE: • Porcentaje de participantes con mediciones anómalas de constantes vitales clínicamente significativas (frecuencia cardíaca, presión arterial y temperatura corporal) en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"},{"id":5895662,"uuid":"22ad3581-311e-4067-a510-82b3859ba48d","attributeTranslation":"OLE:  Odsetek uczestników z klinicznie istotnymi nieprawidłowymi pomiarami parametrów życiowych (tętno, ciśnienie krwi i temperatura ciała) w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"}]},{"id":596974,"number":5,"endPoint":"OLE: • Percentage of participants with clinically significant ECG parameters compared to OLE and CORE baseline","isPrimary":true,"endPointTranslations":[{"id":5895664,"uuid":"b9a4614c-b3ad-4e5a-8d05-92ca53ee3a14","attributeTranslation":"OLE: • Porcentaje de participantes con parámetros de ECG clínicamente significativos en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"},{"id":5895665,"uuid":"b9a4614c-b3ad-4e5a-8d05-92ca53ee3a14","attributeTranslation":"OLE:  Odsetek uczestników z klinicznie istotnymi parametrami EKG w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"}]},{"id":596975,"number":6,"endPoint":"OLE: • Incidence of suicidal ideation or behavior, as assessed by the C-SSRS compared to OLE and CORE baseline","isPrimary":true,"endPointTranslations":[{"id":5895667,"uuid":"9278b96c-735b-438d-b8cd-c5839755f32b","attributeTranslation":"OLE:  Częstość występowania myśli lub zachowań samobójczych według oceny C-SSRS w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"},{"id":5895666,"uuid":"9278b96c-735b-438d-b8cd-c5839755f32b","attributeTranslation":"OLE: • Incidencia de ideas de suicidio o comportamiento suicida, evaluada por la escala C-SSRS en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"}]}],"secondaryEndPoints":[{"id":596976,"number":1,"endPoint":"1. Change from baseline in MADRS for [CCI] mg compared to [CCI] mg of BPL- 003 at [CCI]","isPrimary":false,"endPointTranslations":[{"id":5895668,"uuid":"30aae03d-0d18-4d9a-a661-5d5371ce6d47","attributeTranslation":"1. Cambio desde el inicio en la escala MADRS con [CCI] mg en comparación con [CCI] mg de BPL-003 en [CCI]","language":7,"languageDescription":"Spanish"},{"id":5895669,"uuid":"30aae03d-0d18-4d9a-a661-5d5371ce6d47","attributeTranslation":"1. Zmiana od punktu początkowego w skali MADRS dla dawki [CCI] mg w porównaniu z [CCI] mg BPL-003 w[CCI]","language":19,"languageDescription":"Polish"}]},{"id":596977,"number":2,"endPoint":"2. Change from baseline in MADRS for [CCI] mg compared to [CCI] mg of BPL- 003 at [CCI]","isPrimary":false,"endPointTranslations":[{"id":5895670,"uuid":"32492f46-6ec5-47c3-b540-2f92fdbfe4f4","attributeTranslation":"2. Zmiana od punktu początkowego w skali MADRS dla dawki [CCI] mg w porównaniu z [CCI] mg BPL-003 w [CCI]","language":19,"languageDescription":"Polish"},{"id":5895671,"uuid":"32492f46-6ec5-47c3-b540-2f92fdbfe4f4","attributeTranslation":"2. Cambio desde el inicio en la escala MADRS con [CCI] mg en comparación con [CCI] mg de BPL-003 en [CCI]","language":7,"languageDescription":"Spanish"}]},{"id":596978,"number":3,"endPoint":"3. Change from baseline in MADRS for [CCI] mg compared to [CCI] mg of BPL- 003 at [CCI]","isPrimary":false,"endPointTranslations":[{"id":5895673,"uuid":"71ca454f-4c8c-4a59-9291-c159ae9cb867","attributeTranslation":"3. Cambio desde el inicio en la escala MADRS con [CCI] mg en comparación con [CCI] mg de BPL-003 en [CCI]","language":7,"languageDescription":"Spanish"},{"id":5895672,"uuid":"71ca454f-4c8c-4a59-9291-c159ae9cb867","attributeTranslation":"3. Zmiana od punktu początkowego w skali MADRS dla dawki [CCI] mg w porównaniu do dawki [CCI] mg BPL-003 w [CCI]","language":19,"languageDescription":"Polish"}]},{"id":596979,"number":4,"endPoint":"4. Number of events and percentage of participants with treatment - emergent adverse events (TEAEs)","isPrimary":false,"endPointTranslations":[{"id":5895674,"uuid":"7ef4f680-ea14-4aa0-ba27-d48f93c6398e","attributeTranslation":"4. Liczba zdarzeń i odsetek uczestników ze zdarzeniami niepożądanymi związanymi z leczeniem (treatment-emergent adverse events, TEAE)","language":19,"languageDescription":"Polish"},{"id":5895675,"uuid":"7ef4f680-ea14-4aa0-ba27-d48f93c6398e","attributeTranslation":"4. Número de acontecimientos y porcentaje de participantes con acontecimientos adversos aparecidos durante el tratamiento (AADT)","language":7,"languageDescription":"Spanish"}]},{"id":596980,"number":5,"endPoint":"5. Percentage of participants with clinically significant abnormal laboratory tests compared to baseline","isPrimary":false,"endPointTranslations":[{"id":5895676,"uuid":"f9d7c725-3cee-48f5-bd73-bf3500df1d58","attributeTranslation":"5. Porcentaje de participantes con resultados anómalos de pruebas analíticas clínicamente significativos en comparación con el inicio del estudio","language":7,"languageDescription":"Spanish"},{"id":5895677,"uuid":"f9d7c725-3cee-48f5-bd73-bf3500df1d58","attributeTranslation":"5. Odsetek uczestników z klinicznie istotnymi nieprawidłowymi wynikami badań laboratoryjnych w porównaniu z punktem początkowym","language":19,"languageDescription":"Polish"}]},{"id":596981,"number":6,"endPoint":"6. Percentage of participants with clinically significant abnormal vital sign measurements (heart rate, blood pressure, and body temperature) compared to baseline","isPrimary":false,"endPointTranslations":[{"id":5895679,"uuid":"09214d83-6745-49e1-9c95-e7aee3beda8d","attributeTranslation":"6. Porcentaje de participantes con mediciones anómalas de constantes vitales clínicamente significativas (frecuencia cardíaca, presión arterial y temperatura corporal) en comparación con el inicio del estudio","language":7,"languageDescription":"Spanish"},{"id":5895678,"uuid":"09214d83-6745-49e1-9c95-e7aee3beda8d","attributeTranslation":"6. Odsetek uczestników z klinicznie istotnymi nieprawidłowymi pomiarami parametrów życiowych (tętno, ciśnienie krwi i temperatura ciała) w porównaniu z punktem początkowym","language":19,"languageDescription":"Polish"}]},{"id":596982,"number":7,"endPoint":"7. Percentage of participants with clinically significant electrocardiogram (ECG) parameters compared to baseline","isPrimary":false,"endPointTranslations":[{"id":5895680,"uuid":"b4a5bb0b-1a11-46b6-b6d3-2efd491b196b","attributeTranslation":"7. Porcentaje de participantes con parámetros del electrocardiograma (ECG) clínicamente significativos en comparación con el inicio del estudio","language":7,"languageDescription":"Spanish"},{"id":5895681,"uuid":"b4a5bb0b-1a11-46b6-b6d3-2efd491b196b","attributeTranslation":"7. Odsetek uczestników z klinicznie istotnymi parametrami badania elektrokardiograficznego (EKG) w porównaniu z punktem początkowym","language":19,"languageDescription":"Polish"}]},{"id":596983,"number":8,"endPoint":"8. Incidence of suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) at [CCI] compared to baseline","isPrimary":false,"endPointTranslations":[{"id":5895683,"uuid":"b00d20f6-eb38-44b2-a29a-71396e9dfcb2","attributeTranslation":"8. Incidencia de ideas de suicidio o comportamiento suicida, evaluada por la escala de evaluación del riesgo de suicidio de Columbia (Columbia-Suicide Severity Rating Scale, C-SSRS) en [CCI] en comparación con el inicio del estudio","language":7,"languageDescription":"Spanish"},{"id":5895682,"uuid":"b00d20f6-eb38-44b2-a29a-71396e9dfcb2","attributeTranslation":"8. Częstość występowania myśli lub zachowań samobójczych, oceniana za pomocą skali oceny nasilenia samobójstw (Columbia-Suicide Severity Rating Scale, C-SSRS) w [CCI] w porównaniu z punktem początkowym","language":19,"languageDescription":"Polish"}]},{"id":596984,"number":9,"endPoint":"9. Impairment in cognitive performance, assessed by Cognitive Test Battery at [CCI] compared to baseline","isPrimary":false,"endPointTranslations":[{"id":5895685,"uuid":"4d7e6fb8-003a-4687-81dd-8cdae548de18","attributeTranslation":"9. Upośledzenie funkcji poznawczych oceniane za pomocą baterii testów poznawczych w [CCI] w porównaniu z punktem początkowym","language":19,"languageDescription":"Polish"},{"id":5895684,"uuid":"4d7e6fb8-003a-4687-81dd-8cdae548de18","attributeTranslation":"9. Deterioro en el rendimiento cognitivo, evaluado mediante una serie de pruebas cognitivas en [CCI] en comparación con el inicio del estudio","language":7,"languageDescription":"Spanish"}]},{"id":596985,"number":10,"endPoint":"10. Plasma levels of 5-MeO-DMT and its metabolites (including bufotenine) up to [CCI] after nasal administration of BPL-003","isPrimary":false,"endPointTranslations":[{"id":5895686,"uuid":"6429201d-4be6-45cd-9e41-08e8f97f5c2a","attributeTranslation":"10. Stężenie 5-MeO-DMT i jej metabolitów (w tym bufoteniny) w osoczu do [CCI] po donosowym podaniu BPL-003","language":19,"languageDescription":"Polish"},{"id":5895687,"uuid":"6429201d-4be6-45cd-9e41-08e8f97f5c2a","attributeTranslation":"10. Niveles plasmáticos de 5-MeO-DMT y sus metabolitos (incluida la bufotenina) hasta [CCI] después de la administración nasal de BPL-003","language":7,"languageDescription":"Spanish"}]},{"id":596986,"number":11,"endPoint":"11. Change from baseline in MADRS for [CCI] mg and [CCI] mg of BPL-003 compared to [CCI] mg of BPL-003 at [CCI]","isPrimary":false,"endPointTranslations":[{"id":5895688,"uuid":"55156cb8-9f2b-4c36-ba87-2bd5f32e614b","attributeTranslation":"11. Zmiana od punktu początkowego w skali MADRS dla [CCI] mg i [CCI] mg BPL-003 w porównaniu z [CCI] mg BPL-003 w [CCI]","language":19,"languageDescription":"Polish"},{"id":5895689,"uuid":"55156cb8-9f2b-4c36-ba87-2bd5f32e614b","attributeTranslation":"11. Cambio desde el inicio en la escala MADRS con [CCI] mg y [CCI] mg de BPL-003 en comparación con [CCI] mg de BPL-003 en [CCI]","language":7,"languageDescription":"Spanish"}]},{"id":596987,"number":12,"endPoint":"12. Percentage of responders (defined as 50% reduction in MADRS total score) at [CCI] compared to baseline, by dose group","isPrimary":false,"endPointTranslations":[{"id":5895690,"uuid":"96fc51c1-fd38-4127-a10b-0234883507b1","attributeTranslation":"12. Odsetek pacjentów z odpowiedzią (zdefiniowany jako zmniejszenie o 50%całkowitej punktacji w skali MADRS) w [CCI] w porównaniu z punktem początkowym w podziale na grupy dawkowania","language":19,"languageDescription":"Polish"},{"id":5895691,"uuid":"96fc51c1-fd38-4127-a10b-0234883507b1","attributeTranslation":"12. Porcentaje de participantes que responden al tratamiento (definido como una reducción del 50 % en la puntuación total de la escala MADRS) en [CCI] en comparación con el inicio del estudio, por grupo de dosis","language":7,"languageDescription":"Spanish"}]},{"id":596988,"number":13,"endPoint":"13. Percentage of participants in remission (defined as MADRS total score ≤ 10) at [CCI] by dose group","isPrimary":false,"endPointTranslations":[{"id":5895692,"uuid":"cb2a16d8-667b-46a8-9080-7deaa14cc124","attributeTranslation":"13. Porcentaje de participantes en remisión (definida como una puntuación total de la escala MADRS ≤10) en [CCI] por grupo de dosis","language":7,"languageDescription":"Spanish"},{"id":5895693,"uuid":"cb2a16d8-667b-46a8-9080-7deaa14cc124","attributeTranslation":"13. Odsetek uczestników z remisją (zdefiniowaną jako całkowity wynik w skali MADRS ≤10) w [CCI] w podziale na grupy dawkowania","language":19,"languageDescription":"Polish"}]},{"id":596989,"number":14,"endPoint":"14. Change in 16-item Quick Inventory of Depressive Symptomatology- Self-Report (QIDS-SR-16) score at [CCI] compared to baseline, by dose group","isPrimary":false,"endPointTranslations":[{"id":5895694,"uuid":"cae37497-e6b4-44a7-847e-344c3b727e60","attributeTranslation":"14. Zmiana w 16-elementowej szybkiej skali objawów depresji wg oceny chorego (Quick Inventory of Depressive\nSymptomatology-Self-Report, QIDS-SR-16) w [CCI] w porównaniu z punktem początkowym, w podziale na grupy dawkowania","language":19,"languageDescription":"Polish"},{"id":5895695,"uuid":"cae37497-e6b4-44a7-847e-344c3b727e60","attributeTranslation":"14. Cambio en la puntuación del inventario rápido de autoinforme de sintomatología depresiva de 16 ítems (16-item Quick Inventory of Depressive Symptomatology-Self-Report, QIDS-SR-16) en [CCI] en comparación con el inicio del estudio, por grupo de dosis","language":7,"languageDescription":"Spanish"}]},{"id":596990,"number":15,"endPoint":"15. Change in Quality of Life in Depression Scale (QLDS) score at [CCI] compared to baseline, by dose group","isPrimary":false,"endPointTranslations":[{"id":5895697,"uuid":"00c59cd9-7c3f-4add-9384-9f9bf62d42ad","attributeTranslation":"15. Zmiana wyniku w skali jakości życia w depresji (Quality of Life in Depression Scale, QLDS) w [CCI] w porównaniu z punktem początkowym, w podziale na grupy dawkowania","language":19,"languageDescription":"Polish"},{"id":5895696,"uuid":"00c59cd9-7c3f-4add-9384-9f9bf62d42ad","attributeTranslation":"15. Cambio en la puntuación de la escala de calidad de vida para la depresión (Quality of Life in Depression Scale, QLDS) en [CCI] en comparación con el inicio del estudio, por grupo de dosis","language":7,"languageDescription":"Spanish"}]},{"id":596991,"number":16,"endPoint":"16. Change in Sheehan Disability Scale (SDS) total score at [CCI] compared to baseline, by dose group","isPrimary":false,"endPointTranslations":[{"id":5895698,"uuid":"03a0dc00-a3e6-494a-99fc-9bf0122b383c","attributeTranslation":"16. Cambio en la puntuación total de la escala de discapacidad de Sheehan (Sheehan Disability Scale, SDS) en [CCI] en comparación con el inicio del estudio, por grupo de dosis","language":7,"languageDescription":"Spanish"},{"id":5895699,"uuid":"03a0dc00-a3e6-494a-99fc-9bf0122b383c","attributeTranslation":"16. Zmiana całkowitego wyniku w Skala Niepełnosprawności Sheehana (Sheehan Disability Scale, SDS) w [CCI] w porównaniu z punktem początkowym, w podziale na grupy dawkowania","language":19,"languageDescription":"Polish"}]},{"id":596992,"number":17,"endPoint":"17. Change in Clinical Global Impression-Severity (CGI-S) score at [CCI] compared to baseline, by dose group","isPrimary":false,"endPointTranslations":[{"id":5895701,"uuid":"33190288-9cae-4279-a401-e52041e8355a","attributeTranslation":"17. Zmiana w punktacji w skali ogólnego wrażenia klinicznego ciężkości objawów (Clinical Global Impression-Severity, CGI-S) w [CCI] w porównaniu z punktem początkowym, w podziale na grupy dawkowania","language":19,"languageDescription":"Polish"},{"id":5895700,"uuid":"33190288-9cae-4279-a401-e52041e8355a","attributeTranslation":"17. Cambio en la puntuación de la escala de impresión global clínica de gravedad (Clinical Global Impression-Severity, CGI-S) en [CCI] en comparación con el inicio del estudio, por grupo de dosis","language":7,"languageDescription":"Spanish"}]},{"id":596993,"number":18,"endPoint":"OLE: 1. Change in MADRS compared to OLE and CORE baseline","isPrimary":false,"endPointTranslations":[{"id":5895702,"uuid":"a3116f6a-11aa-4cfd-9fc4-d696be424f04","attributeTranslation":"OLE: 1. Zmiana w skali MADRS w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"},{"id":5895703,"uuid":"a3116f6a-11aa-4cfd-9fc4-d696be424f04","attributeTranslation":"OLE: 1. Cambio en la escala MADRS en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"}]},{"id":596994,"number":19,"endPoint":"OLE: 2. Percentage of responders (defined as 50% reduction in MADRS total score) compared to OLE and CORE baseline","isPrimary":false,"endPointTranslations":[{"id":5895704,"uuid":"608a38c4-583b-4f96-a9ce-7e2e090a8d6b","attributeTranslation":"OLE: 2. Porcentaje de participantes que responden al tratamiento (definido como una reducción del 50 % en la puntuación total de la escala MADRS) en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"},{"id":5895705,"uuid":"608a38c4-583b-4f96-a9ce-7e2e090a8d6b","attributeTranslation":"OLE: 2. Odsetek pacjentów z odpowiedzią (zdefiniowany jako zmniejszenie o 50% całkowitego wyniku MADRS) w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"}]},{"id":596995,"number":20,"endPoint":"OLE: 3. Percentage of participants in remission (defined as MADRS total score ≤ 10) compared to OLE and CORE baseline","isPrimary":false,"endPointTranslations":[{"id":5895707,"uuid":"e30c53a4-f210-42fa-ad2e-c60ab4d343b5","attributeTranslation":"OLE: 3. Porcentaje de participantes en remisión (definida como una puntuación total de la escala MADRS ≤10) en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"},{"id":5895706,"uuid":"e30c53a4-f210-42fa-ad2e-c60ab4d343b5","attributeTranslation":"OLE: 3. Odsetek uczestników z remisją (zdefiniowaną jako całkowity wynik w skali MADRS ≤10) w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"}]},{"id":596996,"number":21,"endPoint":"OLE: 4. Plasma levels of 5-MeO-DMT and its metabolites (including bufotenine) up to [CCI] after nasal administration of BPL-003","isPrimary":false,"endPointTranslations":[{"id":5895708,"uuid":"edb4f031-499e-4724-b7a5-63b468d5ceb0","attributeTranslation":"OLE: 4. Niveles plasmáticos de 5-MeO-DMT y sus metabolitos (incluida la bufotenina) hasta [CCI] después de la administración nasal de BPL-003","language":7,"languageDescription":"Spanish"},{"id":5895709,"uuid":"edb4f031-499e-4724-b7a5-63b468d5ceb0","attributeTranslation":"OLE: 4. Stężenie 5-MeO-DMT i jej metabolitów (w tym bufoteniny) w osoczu do [CCI] po donosowym podaniu BPL-003","language":19,"languageDescription":"Polish"}]},{"id":596997,"number":22,"endPoint":"OLE: 5. Change in QIDS-SR-16 score compared to OLE and CORE baseline","isPrimary":false,"endPointTranslations":[{"id":5895711,"uuid":"ea0babd3-43eb-4353-98de-0132ae70112a","attributeTranslation":"OLE: 5. Zmiana wyniku QIDS-SR-16 w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"},{"id":5895710,"uuid":"ea0babd3-43eb-4353-98de-0132ae70112a","attributeTranslation":"OLE: 5. Cambio en la puntuación de QIDS-SR-16 en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"}]},{"id":596998,"number":23,"endPoint":"OLE: 6. Change in QLDS score compared to OLE and CORE baseline","isPrimary":false,"endPointTranslations":[{"id":5895713,"uuid":"00f022f6-df9b-46a5-a3ec-3d7bcc6bbe03","attributeTranslation":"OLE: 6. Cambio en la puntuación de QLDS en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"},{"id":5895712,"uuid":"00f022f6-df9b-46a5-a3ec-3d7bcc6bbe03","attributeTranslation":"OLE: 6. Zmiana wyniku QLDS w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"}]},{"id":596999,"number":24,"endPoint":"OLE: 7. Change in SDS total score compared to OLE and CORE baseline","isPrimary":false,"endPointTranslations":[{"id":5895714,"uuid":"f9d1e59d-0362-4731-8a07-85a4accb2488","attributeTranslation":"OLE: 7. Cambio en la puntuación total de SDS en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"},{"id":5895715,"uuid":"f9d1e59d-0362-4731-8a07-85a4accb2488","attributeTranslation":"OLE: 7. Zmiana całkowitego wyniku SDS w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"}]},{"id":597000,"number":25,"endPoint":"OLE: 8. Change in CGI-S score compared to OLE and CORE baseline","isPrimary":false,"endPointTranslations":[{"id":5895716,"uuid":"388bca27-5380-4af4-b3ec-63a12cf9e7cd","attributeTranslation":"OLE: 8. Cambio en la puntuación de CGI-S en comparación con el inicio del CORE y la OLE del estudio","language":7,"languageDescription":"Spanish"},{"id":5895717,"uuid":"388bca27-5380-4af4-b3ec-63a12cf9e7cd","attributeTranslation":"OLE: 8. Zmiana wyniku CGI-S w porównaniu z punktem początkowym w OLE i BADANIU GŁÓWNYM","language":19,"languageDescription":"Polish"}]}]},"trialDuration":{"estimatedGlobalEndDate":"2025-06-27","estimatedEndDate":"2025-03-07","estimatedRecruitmentStartDate":"2023-11-15"},"sourceOfMonetarySupport":[{"id":56501,"organisationName":"Beckley Psytech Ltd."}],"populationOfTrialSubjects":{"ageRanges":[{"id":215072,"ageRangeCategoryCode":"3","ageRangeCategory":"3"},{"id":215071,"ageRangeCategoryCode":"4","ageRangeCategory":"4"}],"ageRangeSecondaryIds":[{"id":215073,"ageRangeCategoryCode":"4","ctAgeRangeCode":"7","ageRangeCategory":"4","ctAgeRange":"7"}],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":true},"individualParticipantData":{"planToShareIPD":"2"}},"protocolInformation":{},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-20","conclusionDate":"2024-09-20","therapeuticAreas":[{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"}],"medicalConditions":[{"id":80697,"medicalCondition":"Treatment-Resistant Depression (TRD)","isConditionRareDisease":false}],"sponsors":[{"id":86113,"primary":true,"publicContacts":[{"id":257033,"type":"Public","functionalName":"Clinical Trial Information","functionalEmailAddress":"Medinfo@beckleypsytech.com","telephone":"+441865987633","organisation":{"id":436215,"type":"Pharmaceutical company","typeCode":"10","name":"Beckley Psytech Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100026631","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":257034,"type":"Scientific","functionalName":"Associate Director, Clinical Science","functionalEmailAddress":"chandni.hindocha@beckleypsytech.com","telephone":"+447707235034","organisation":{"id":436215,"type":"Pharmaceutical company","typeCode":"10","name":"Beckley Psytech Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100026631","organisationLocationStatus":"Active"}}],"thirdParties":[{"id":370586,"organisationAddress":{"id":438030,"organisation":{"id":470278,"type":"Non-Pharmaceutical company","typeCode":"11","name":"Evident Studio Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100051690","organisationLocationStatus":"Active"},"address":{"addressId":468927,"oneLine":"Lantic, Polsethow","addressLine1":"Lantic","addressLine2":"Polsethow","addressLine3":"","addressLine4":"","city":"Penryn","postcode":"TR10 8PA","country":826,"countryName":"United Kingdom"},"phone":"+107801480820","email":"mark@evident.studio","isBusinessKeyValidated":true,"businessKey":"ORG-100051690"},"sponsorDuties":[{"id":581131,"code":"15","value":"Handling data created by online pre-screener"}],"phoneNumber":"+107801480820","email":"mark@evident.studio"},{"id":370590,"organisationAddress":{"id":415703,"organisation":{"id":447567,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Acm Global Central Laboratory Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042459","organisationLocationStatus":"Active"},"address":{"addressId":444625,"oneLine":"23 Hospital Fields Road, Fulford Industrial Estate","addressLine1":"23 Hospital Fields Road","addressLine2":"Fulford Industrial Estate","addressLine3":"","addressLine4":"","city":"York","postcode":"YO10 4DZ","country":826,"countryName":"United Kingdom"},"phone":"+44918777075","email":"hana.jelassi@acmgloballab.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042459"},"sponsorDuties":[{"id":581135,"code":"15","value":"Clinical chemistry, Clinical haematology"}],"phoneNumber":"+44918777075","email":"hana.jelassi@acmgloballab.com"},{"id":370587,"organisationAddress":{"id":452975,"organisation":{"id":485272,"type":"Industry","typeCode":"3","name":"Typeform, S.L.","commercial":true,"isBusinessKeyValidated":false,"businessKey":"ORL-000007836","organisationLocationStatus":"Active"},"address":{"addressId":485413,"oneLine":"Can Rabia, 3-5, 4th floor","addressLine1":"Can Rabia, 3-5","addressLine2":"4th floor","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08017","country":2027,"countryName":"Spain"},"phone":"+34931857826","email":"mitchell.canfield@typeform.com","isBusinessKeyValidated":false,"businessKey":"ORL-000007836"},"sponsorDuties":[{"id":581132,"code":"15","value":"E-data capture"}],"phoneNumber":"+34931857826","email":"mitchell.canfield@typeform.com"},{"id":370591,"organisationAddress":{"id":438012,"organisation":{"id":470260,"type":"Pharmaceutical company","typeCode":"10","name":"Eramol (UK) Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100013919","organisationLocationStatus":"Active"},"address":{"addressId":468909,"oneLine":"Unit 9, North Downs Business Park, Limepit Lane, Dunton Green","addressLine1":"Unit 9","addressLine2":"North Downs Business Park","addressLine3":"Limepit Lane","addressLine4":"Dunton Green","city":"Sevenoaks","postcode":"TN13 2TL","country":826,"countryName":"United Kingdom"},"phone":"+441293368080","email":"QA.team@eramol.com","isBusinessKeyValidated":true,"businessKey":"ORG-100013919"},"sponsorDuties":[{"id":581136,"code":"15","value":"IP distributer"}],"phoneNumber":"+441293368080","email":"QA.team@eramol.com"},{"id":370595,"organisationAddress":{"id":437998,"organisation":{"id":470246,"type":"Non-Pharmaceutical company","typeCode":"11","name":"Suvoda LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100043523","organisationLocationStatus":"Active"},"address":{"addressId":468895,"oneLine":"181 Washington Street Suite 100","addressLine1":"181 Washington Street Suite 100","addressLine2":"","addressLine3":"","addressLine4":"","city":"Conshohocken","postcode":"19428-2082","country":840,"countryName":"United States"},"phone":"+14844523696","email":"qualityassurance@suvoda.com","isBusinessKeyValidated":true,"businessKey":"ORG-100043523"},"sponsorDuties":[{"id":581140,"code":"3"}],"phoneNumber":"+14844523696","email":"qualityassurance@suvoda.com"},{"id":370593,"organisationAddress":{"id":445582,"organisation":{"id":477855,"type":"Pharmaceutical company","typeCode":"10","name":"Merative France","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100051850","organisationLocationStatus":"Active"},"address":{"addressId":477249,"oneLine":"3 Boulevard De Sebastopol","addressLine1":"3 Boulevard De Sebastopol","addressLine2":"","addressLine3":"","addressLine4":"","city":"Paris","postcode":"75001","country":2012,"countryName":"France"},"phone":"+35315846141","email":"sadok.lahbairi@merative.com","isBusinessKeyValidated":true,"businessKey":"ORG-100051850"},"sponsorDuties":[{"id":581138,"code":"7"}],"phoneNumber":"+35315846141","email":"sadok.lahbairi@merative.com"},{"id":370592,"organisationAddress":{"id":438008,"organisation":{"id":470256,"type":"Non-Pharmaceutical company","typeCode":"11","name":"Taxi Travel Ticket S.L.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042292","organisationLocationStatus":"Active"},"address":{"addressId":468905,"oneLine":"Calle Plom 5-7 5º 1ª, Poligono Industrial De La Zona Franca","addressLine1":"Calle Plom 5-7 5º 1ª","addressLine2":"Poligono Industrial De La Zona Franca","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08038","country":2027,"countryName":"Spain"},"phone":"+34900645245","email":"ensayos@bonotaxi.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042292"},"sponsorDuties":[{"id":581137,"code":"15","value":"Taxi reimbursement service"}],"phoneNumber":"+34900645245","email":"ensayos@bonotaxi.com"},{"id":370585,"organisationAddress":{"id":415683,"organisation":{"id":447547,"type":"Pharmaceutical company","typeCode":"10","name":"Worldwide Clinical Trials d.o.o.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100030991","organisationLocationStatus":"Active"},"address":{"addressId":444600,"oneLine":"Ulica Grada Vukovara 284","addressLine1":"Ulica Grada Vukovara 284","addressLine2":"","addressLine3":"","addressLine4":"","city":"Zagreb","postcode":"10000","country":2006,"countryName":"Croatia"},"phone":"+447825664870","email":"Daniel.Trim@worldwide.com","isBusinessKeyValidated":true,"businessKey":"ORG-100030991"},"sponsorDuties":[{"id":581123,"code":"1"},{"id":581124,"code":"10"},{"id":581125,"code":"11"},{"id":581126,"code":"12"},{"id":581127,"code":"2"},{"id":581128,"code":"5"},{"id":581129,"code":"6"},{"id":581130,"code":"8"}],"phoneNumber":"+447825664870","email":"Daniel.Trim@worldwide.com"},{"id":370594,"organisationAddress":{"id":437995,"organisation":{"id":470243,"type":"Pharmaceutical company","typeCode":"10","name":"Analytical Services International Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100051741","organisationLocationStatus":"Active"},"address":{"addressId":468892,"oneLine":"Aspect House, Grove Business Park","addressLine1":"Aspect House","addressLine2":"Grove Business Park","addressLine3":"","addressLine4":"","city":"Wantage","postcode":"OX12 9FA","country":826,"countryName":"United Kingdom"},"phone":"+442087252845","email":"jacqui.dokoupil@bioanalytics.co.uk","isBusinessKeyValidated":true,"businessKey":"ORG-100051741"},"sponsorDuties":[{"id":581139,"code":"15","value":"PK analysis"}],"phoneNumber":"+442087252845","email":"jacqui.dokoupil@bioanalytics.co.uk"},{"id":370589,"organisationAddress":{"id":439272,"organisation":{"id":471523,"type":"Pharmaceutical company","typeCode":"10","name":"Eresearchtechnology Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100013039","organisationLocationStatus":"Active"},"address":{"addressId":470272,"oneLine":"1818 Market Street Ste 2600","addressLine1":"1818 Market Street Ste 2600","addressLine2":"","addressLine3":"","addressLine4":"","city":"Philadelphia","postcode":"19103-3600","country":840,"countryName":"United States"},"phone":"+4915144164537","email":"yu-hsuan.chien-denk@clario.com","isBusinessKeyValidated":true,"businessKey":"ORG-100013039"},"sponsorDuties":[{"id":581134,"code":"15","value":"ECG analysis/ review"}],"phoneNumber":"+4915144164537","email":"yu-hsuan.chien-denk@clario.com"},{"id":370588,"organisationAddress":{"id":415728,"organisation":{"id":447593,"type":"Pharmaceutical company","typeCode":"10","name":"Clinical Ink Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042433","organisationLocationStatus":"Active"},"address":{"addressId":444652,"oneLine":"159 Gibraltar Road","addressLine1":"159 Gibraltar Road","addressLine2":"","addressLine3":"","addressLine4":"","city":"Horsham","postcode":"19044-2303","country":840,"countryName":"United States"},"phone":"+16319874589","email":"Compliance@ClinicalInk.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042433"},"sponsorDuties":[{"id":581133,"code":"15","value":"eCOA / study scales"}],"phoneNumber":"+16319874589","email":"Compliance@ClinicalInk.com"},{"id":370583,"organisationAddress":{"id":438005,"organisation":{"id":470253,"type":"Non-Pharmaceutical company","typeCode":"11","name":"Quipment","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100043496","organisationLocationStatus":"Active"},"address":{"addressId":468902,"oneLine":"269 Rue Julie Victoire Daubie","addressLine1":"269 Rue Julie Victoire Daubie","addressLine2":"","addressLine3":"","addressLine4":"","city":"Nancy","postcode":"54100","country":2012,"countryName":"France"},"phone":"+33372470468","email":"salesadministration@quipment.fr","isBusinessKeyValidated":true,"businessKey":"ORG-100043496"},"sponsorDuties":[{"id":581121,"code":"15","value":"Ad hoc equipment support"}],"phoneNumber":"+33372470468","email":"salesadministration@quipment.fr"},{"id":370584,"organisationAddress":{"id":452236,"organisation":{"id":484532,"type":"Educational Institution","typeCode":"1","name":"Fluence International Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100051892","organisationLocationStatus":"Active"},"address":{"addressId":484599,"oneLine":"132 West 169th Street","addressLine1":"132 West 169th Street","addressLine2":"","addressLine3":"","addressLine4":"","city":"Bronx","postcode":"10452-2824","country":840,"countryName":"United States"},"phone":"+19177191079","email":"elizabeth@fluencetraining.com","isBusinessKeyValidated":true,"businessKey":"ORG-100051892"},"sponsorDuties":[{"id":581122,"code":"15","value":"Therapist training"}],"phoneNumber":"+19177191079","email":"elizabeth@fluencetraining.com"}],"organisation":{"id":436215,"type":"Pharmaceutical company","typeCode":"10","name":"Beckley Psytech Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100026631","organisationLocationStatus":"Active"},"addresses":[{"id":404381,"organisation":{"id":436215,"type":"Pharmaceutical company","typeCode":"10","name":"Beckley Psytech Limited","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100026631","organisationLocationStatus":"Active"},"address":{"addressId":432383,"oneLine":"Beckley Park Farm, Beckley","addressLine1":"Beckley Park Farm","addressLine2":"Beckley","addressLine3":"","addressLine4":"","city":"Oxford","postcode":"OX3 9SY","country":826,"countryName":"United Kingdom"},"isBusinessKeyValidated":true,"businessKey":"ORG-100026631"}],"isCommercial":true,"commercial":"Commercial"}],"trialCategoryCode":"2","trialCategoryJustificationComment":"Therapeutic Exploratory (Phase II)","partOneTherapeuticAreas":[{"id":828098,"therapeuticArea":{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"}}],"productRoleGroupInfos":[{"id":247167,"miaNumber":"IMP12512/0001","productRoleCode":"1","productRoleName":"Test","products":[{"id":324629,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11559479","euMpNumber":"PRD10167923","prodAuthStatus":1,"sponsorProductCode":"BPL-003","euSubstNumber":"SUB299297","nameOrg":"BECKLEY PSYTECH LTD","productSubstances":[{"productPk":"11559479","substancePk":"372627","nameOrg":"BECKLEY PSYTECH LTD","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","substanceEvCode":"SUB299297","synonyms":["BPL-003 benzoate","5-Methoxy-N,N-dimethyltryptamine benzoate","5-MeO-DMT benzoate"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"otherMedicinalProduct":"Chemical","evCode":"PRD10167923","sponsorProductCodeEdit":"BPL-003","miaNumber":"IMP12512/0001","devices":[],"characteristics":["11"],"allSubstancesChemicals":true},{"id":324630,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11559592","euMpNumber":"PRD10167932","prodAuthStatus":1,"sponsorProductCode":"BPL-003","euSubstNumber":"SUB299297","nameOrg":"BECKLEY PSYTECH LTD","productSubstances":[{"productPk":"11559592","substancePk":"372627","nameOrg":"BECKLEY PSYTECH LTD","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","substanceEvCode":"SUB299297","synonyms":["BPL-003 benzoate","5-Methoxy-N,N-dimethyltryptamine benzoate","5-MeO-DMT benzoate"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"otherMedicinalProduct":"Chemical","evCode":"PRD10167932","sponsorProductCodeEdit":"BPL-003","miaNumber":"IMP12512/0001","devices":[],"characteristics":["11"],"allSubstancesChemicals":true}]}],"isLowIntervention":false},"authorizedPartsII":[{"id":86913,"mscId":28194,"mscInfo":{"id":28194,"clinicalTrialId":14288,"countryOrganisationId":2013,"reportingStatusCode":"Ended","fromDate":"2024-09-19","toDate":"2024-09-19","isProposedRms":true,"expressDecision":"willing","countryName":"Germany","organisationInfo":{},"firstDecisionDate":"2024-09-26","trialStatus":"Ended","trialPeriod":[{"id":36113,"trialStartDate":"2023-11-07","fromDate":"2024-09-26"},{"id":36182,"trialStartDate":"2023-11-07","fromDate":"2024-09-27"},{"id":60381,"trialStartDate":"2023-11-07","trialEndDate":"2025-07-03","fromDate":"2025-07-08"}],"trialRecruitmentPeriod":[{"id":47112,"recruitmentStartDate":"2023-11-27","fromDate":"2024-09-27"},{"id":47113,"recruitmentStartDate":"2023-11-27","fromDate":"2024-09-27"},{"id":47088,"recruitmentStartDate":"2023-11-27","fromDate":"2024-09-27"},{"id":66234,"recruitmentStartDate":"2023-11-27","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"},{"id":66307,"recruitmentStartDate":"2023-11-27","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"},{"id":66308,"recruitmentStartDate":"2023-11-27","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":89620,"trialStartDate":"2023-11-07","trialEndDate":"2025-07-03","fromDate":"2024-09-26","isBenefitRiskBalanceTemporaryHalt":false,"isBenefitRiskBalanceEndTrail":false,"isTemporaryHalt":false,"isEndTrial":true},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2023-11-27","recruitmentEndDate":"2025-01-31"},"isWillingAtDayThreeView":true,"clinicalTrialStatusHistory":[{"id":54048,"mscId":28194,"trialStatus":"Authorised","trialStatusDate":"2024-09-26T15:33:40.238"},{"id":51909,"mscId":28194,"trialStatus":"Under evaluation","trialStatusDate":"2024-09-11T11:47:35.789"},{"id":87136,"mscId":28194,"trialStatus":"Ended","trialStatusDate":"2025-07-08T16:38:18.368"}],"applicationTypeMsc":"1","mscName":"Germany","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-24","decision":"authorized","decisionDate":"2024-09-26"},"decisionDate":"2024-09-26","recruitmentSubjectCount":26,"trialSites":[{"id":875433,"organisationAddressInfo":{"id":581439,"organisation":{"id":614181,"type":"Health care","typeCode":"2","name":"Universitätsklinikum Frankfurt","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000010428","organisationLocationStatus":"Active"},"address":{"addressId":626924,"oneLine":"Heinrich-Hoffmann-Str. 10, Klinik für Psychiatrie, Psychosomatik und Psychotherapie","addressLine1":"Heinrich-Hoffmann-Str. 10","addressLine2":"Klinik für Psychiatrie, Psychosomatik und Psychotherapie","addressLine3":"","addressLine4":"","city":"Frankfurt am Main","postcode":"60528","country":2013,"countryName":"Germany"},"phone":"+4969630187300","email":"andreas.reif@kgu.de","isBusinessKeyValidated":false,"businessKey":"ORL-000010428"},"personInfo":{"id":976939,"firstName":"Andreas","lastName":"Reif","telephone":"+4969630187300","email":"andreas.reif@kgu.de","title":"2"},"departmentName":"Psychosomatik und Psychotherapie"},{"id":875457,"organisationAddressInfo":{"id":581467,"organisation":{"id":614209,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"OVID Clinic Berlin GmbH","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100047707","organisationLocationStatus":"Active"},"address":{"addressId":626953,"oneLine":"Boxhagener Strasse 82, Friedrichshain","addressLine1":"Boxhagener Strasse 82","addressLine2":"Friedrichshain","addressLine3":"","addressLine4":"","city":"Berlin","postcode":"10245","country":2013,"countryName":"Germany"},"phone":"+493029367333","email":"info@ovid-clinics.com","isBusinessKeyValidated":true,"businessKey":"ORG-100047707"},"personInfo":{"id":976964,"firstName":"Andrea","lastName":"Jungaberle","telephone":"+493029367333","email":"info@ovid-clinics.com","title":"1"},"departmentName":"Medical Direction"},{"id":875454,"organisationAddressInfo":{"id":581462,"organisation":{"id":614204,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Zentralinstitut Fuer Seelische Gesundheit","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100013535","organisationLocationStatus":"Active"},"address":{"addressId":626948,"oneLine":"Luisenring J 5","addressLine1":"Luisenring J 5","addressLine2":"","addressLine3":"","addressLine4":"","city":"Mannheim","postcode":"68159","country":2013,"countryName":"Germany"},"phone":"+4962117031900","email":"gerhard.gruender@zi-mannheim.de","isBusinessKeyValidated":true,"businessKey":"ORG-100013535"},"personInfo":{"id":976961,"firstName":"Gerhard","lastName":"Gründer","telephone":"+4962117031900","email":"gerhard.gruender@zi-mannheim.de","title":"1"},"departmentName":"Molecular Neuroimaging"},{"id":875455,"organisationAddressInfo":{"id":581464,"organisation":{"id":614206,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Universitaetsklinikum Tuebingen AöR","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100007980","organisationLocationStatus":"Active"},"address":{"addressId":626950,"oneLine":"Calwerstrasse 14, Innenstadt","addressLine1":"Calwerstrasse 14","addressLine2":"Innenstadt","addressLine3":"","addressLine4":"","city":"Tuebingen","postcode":"72076","country":2013,"countryName":"Germany"},"phone":"+4970712982685","email":"anil.batra@med.uni-tuebingen.de","isBusinessKeyValidated":true,"businessKey":"ORG-100007980"},"personInfo":{"id":976962,"firstName":"Anil","lastName":"Batra","telephone":"+4970712982685","email":"anil.batra@med.uni-tuebingen.de","title":"1"},"departmentName":"Klinik für Psychiatrie und Psychotherapie"},{"id":875453,"organisationAddressInfo":{"id":581459,"organisation":{"id":614201,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Charite Universitaetsmedizin Berlin KöR","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100008480","organisationLocationStatus":"Active"},"address":{"addressId":626945,"oneLine":"Chariteplatz 1, Mitte","addressLine1":"Chariteplatz 1","addressLine2":"Mitte","addressLine3":"","addressLine4":"","city":"Berlin","postcode":"10117","country":2013,"countryName":"Germany"},"phone":"+493045050","email":"dimitris.repantis@charite.de","isBusinessKeyValidated":true,"businessKey":"ORG-100008480"},"personInfo":{"id":976960,"firstName":"Dimitris","lastName":"Repantis","telephone":"+493045050","email":"dimitris.repantis@charite.de","title":"1"},"departmentName":"Psychiatry and Neurosciences"}],"applicationStatusCode":"Authorised"},{"id":86914,"mscId":28195,"mscInfo":{"id":28195,"clinicalTrialId":14288,"countryOrganisationId":2027,"reportingStatusCode":"Ended","fromDate":"2024-09-19","toDate":"2024-09-19","isProposedRms":false,"expressDecision":"unwilling","countryName":"Spain","organisationInfo":{},"firstDecisionDate":"2024-09-24","trialStatus":"Ended","trialPeriod":[{"id":35691,"trialStartDate":"2023-10-24","fromDate":"2024-09-24"},{"id":35693,"trialStartDate":"2023-10-24","fromDate":"2024-09-24"},{"id":36181,"trialStartDate":"2023-10-24","fromDate":"2024-09-27"},{"id":35692,"trialStartDate":"2023-10-24","fromDate":"2024-09-24"},{"id":59285,"trialStartDate":"2023-10-24","trialEndDate":"2025-06-18","fromDate":"2025-06-24"},{"id":59284,"trialStartDate":"2023-10-24","trialEndDate":"2025-06-18","fromDate":"2025-06-24"}],"trialRecruitmentPeriod":[{"id":47087,"recruitmentStartDate":"2024-01-17","fromDate":"2024-09-27"},{"id":47110,"recruitmentStartDate":"2024-01-17","fromDate":"2024-09-27"},{"id":47111,"recruitmentStartDate":"2024-01-17","fromDate":"2024-09-27"},{"id":66235,"recruitmentStartDate":"2024-01-17","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"},{"id":66305,"recruitmentStartDate":"2024-01-17","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"},{"id":66306,"recruitmentStartDate":"2024-01-17","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":87699,"trialStartDate":"2023-10-24","trialEndDate":"2025-06-18","fromDate":"2024-09-24","isBenefitRiskBalanceTemporaryHalt":false,"isBenefitRiskBalanceEndTrail":false,"isTemporaryHalt":false,"isEndTrial":true},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2024-01-17","recruitmentEndDate":"2025-01-31"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":51910,"mscId":28195,"trialStatus":"Under evaluation","trialStatusDate":"2024-09-11T11:47:35.805"},{"id":53594,"mscId":28195,"trialStatus":"Authorised","trialStatusDate":"2024-09-24T11:42:20.342"},{"id":85987,"mscId":28195,"trialStatus":"Ended","trialStatusDate":"2025-06-24T15:35:39.553"}],"applicationTypeMsc":"1","mscName":"Spain","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-24","decision":"authorized","decisionDate":"2024-09-24"},"decisionDate":"2024-09-24","recruitmentSubjectCount":14,"trialSites":[{"id":875913,"organisationAddressInfo":{"id":581612,"organisation":{"id":614355,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Clinic De Barcelona","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100009329","organisationLocationStatus":"Active"},"address":{"addressId":627114,"oneLine":"Calle Villarroel 170","addressLine1":"Calle Villarroel 170","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08036","country":2027,"countryName":"Spain"},"phone":"932275400","email":"Evieta@clinic.cat","isBusinessKeyValidated":true,"businessKey":"ORG-100009329"},"personInfo":{"id":977477,"firstName":"Eduard","lastName":"Vieta Pascal","telephone":"932275400","email":"Evieta@clinic.cat","title":"1"},"departmentName":"-"},{"id":875912,"organisationAddressInfo":{"id":581610,"organisation":{"id":614353,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Universitario Hm Puerta Del Sur","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043292","organisationLocationStatus":"Active"},"address":{"addressId":627112,"oneLine":"Avenida De Carlos V 70","addressLine1":"Avenida De Carlos V 70","addressLine2":"","addressLine3":"","addressLine4":"","city":"Mostoles","postcode":"28938","country":2027,"countryName":"Spain"},"phone":"912673201","email":"lcaballero@hmhospitales.com","isBusinessKeyValidated":true,"businessKey":"ORG-100043292"},"personInfo":{"id":977476,"firstName":"Luis Maria","lastName":"Caballero Martinez","telephone":"912673201","email":"lcaballero@hmhospitales.com","title":"1"},"departmentName":"-"},{"id":875914,"organisationAddressInfo":{"id":581613,"organisation":{"id":614356,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Del Mar","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028631","organisationLocationStatus":"Active"},"address":{"addressId":627115,"oneLine":"Passeig Maritim De La Barceloneta 25-29","addressLine1":"Passeig Maritim De La Barceloneta 25-29","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08003","country":2027,"countryName":"Spain"},"phone":"932483175","email":"vperezsola@psmar.cat","isBusinessKeyValidated":true,"businessKey":"ORG-100028631"},"personInfo":{"id":977478,"firstName":"Victor","lastName":"Perez Sola","telephone":"932483175","email":"vperezsola@psmar.cat","title":"1"},"departmentName":"-"},{"id":875916,"organisationAddressInfo":{"id":581616,"organisation":{"id":614359,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Universitario De Salamanca","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028551","organisationLocationStatus":"Active"},"address":{"addressId":627118,"oneLine":"Paseo De San Vicente 58-182","addressLine1":"Paseo De San Vicente 58-182","addressLine2":"","addressLine3":"","addressLine4":"","city":"Salamanca","postcode":"37007","country":2027,"countryName":"Spain"},"phone":"923291100","email":"amontejo@usal.es","isBusinessKeyValidated":true,"businessKey":"ORG-100028551"},"personInfo":{"id":977480,"firstName":"Angel Luis","lastName":"Montejo Gonzalez","telephone":"923291100","email":"amontejo@usal.es","title":"1"},"departmentName":"-"},{"id":875917,"organisationAddressInfo":{"id":581647,"organisation":{"id":614390,"type":"Health care","typeCode":"2","name":"Centro de Salud Mental La Corredoria","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000010429","organisationLocationStatus":"Active"},"address":{"addressId":627160,"oneLine":"Calle Alfredo Blanco","addressLine1":"Calle Alfredo Blanco","addressLine2":"","addressLine3":"","addressLine4":"","city":"Oviedo","postcode":"33011","country":2027,"countryName":"Spain"},"phone":"+34985104219","email":"albert@uniovi.es","isBusinessKeyValidated":false,"businessKey":"ORL-000010429"},"personInfo":{"id":977481,"firstName":"Maria Paz","lastName":"Garcia-Portilla Gonzalez","telephone":"+34985104219","email":"albert@uniovi.es","title":"1"},"departmentName":"-"},{"id":875915,"organisationAddressInfo":{"id":581614,"organisation":{"id":614357,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Sant Joan De Deu Barcelona","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100023083","organisationLocationStatus":"Active"},"address":{"addressId":627116,"oneLine":"Passeig De Sant Joan De Deu 2","addressLine1":"Passeig De Sant Joan De Deu 2","addressLine2":"","addressLine3":"","addressLine4":"","city":"Esplugues De Llobregat","postcode":"08950","country":2027,"countryName":"Spain"},"phone":"34933249600","email":"rosam.duenas@sjd.es","isBusinessKeyValidated":true,"businessKey":"ORG-100023083"},"personInfo":{"id":977479,"firstName":"Rosa Ma","lastName":"Dueñas Herrero","telephone":"34933249600","email":"rosam.duenas@sjd.es","title":"1"},"departmentName":"-"}],"applicationStatusCode":"Authorised"},{"id":86915,"mscId":28196,"mscInfo":{"id":28196,"clinicalTrialId":14288,"countryOrganisationId":2031,"reportingStatusCode":"Ended","fromDate":"2024-09-19","toDate":"2024-09-19","isProposedRms":false,"expressDecision":"unwilling","countryName":"Poland","organisationInfo":{},"firstDecisionDate":"2024-09-25","trialStatus":"Ended","trialPeriod":[{"id":36180,"trialStartDate":"2023-09-08","fromDate":"2024-09-27"},{"id":35962,"trialStartDate":"2023-09-08","fromDate":"2024-09-25"},{"id":60408,"trialStartDate":"2023-09-08","trialEndDate":"2025-06-26","fromDate":"2025-07-08"}],"trialRecruitmentPeriod":[{"id":47108,"recruitmentStartDate":"2023-09-22","fromDate":"2024-09-27"},{"id":47109,"recruitmentStartDate":"2023-09-22","fromDate":"2024-09-27"},{"id":47086,"recruitmentStartDate":"2023-09-22","fromDate":"2024-09-27"},{"id":66236,"recruitmentStartDate":"2023-09-22","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"},{"id":66303,"recruitmentStartDate":"2023-09-22","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"},{"id":66304,"recruitmentStartDate":"2023-09-22","recruitmentEndDate":"2025-01-31","fromDate":"2025-02-05"}],"hasRecruitmentStarted":true,"activeTrialPeriod":{"id":89651,"trialStartDate":"2023-09-08","trialEndDate":"2025-06-26","fromDate":"2024-09-27","isBenefitRiskBalanceTemporaryHalt":false,"isBenefitRiskBalanceEndTrail":false,"isTemporaryHalt":false,"isEndTrial":true},"activeTrialRecruitmentPeriod":{"recruitmentStartDate":"2023-09-22","recruitmentEndDate":"2025-01-31"},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":53886,"mscId":28196,"trialStatus":"Authorised","trialStatusDate":"2024-09-25T17:38:17.727"},{"id":51911,"mscId":28196,"trialStatus":"Under evaluation","trialStatusDate":"2024-09-11T11:47:35.816"},{"id":87221,"mscId":28196,"trialStatus":"Ended","trialStatusDate":"2025-07-09T15:24:34.404"}],"applicationTypeMsc":"1","mscName":"Poland","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-24","decision":"authorized","decisionDate":"2024-09-25"},"decisionDate":"2024-09-25","recruitmentSubjectCount":47,"trialSites":[{"id":865484,"organisationAddressInfo":{"id":575495,"organisation":{"id":608208,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100018907","organisationLocationStatus":"Active"},"address":{"addressId":620308,"oneLine":"Ul. Czechoslowacka 8/10","addressLine1":"Ul. Czechoslowacka 8/10","addressLine2":"","addressLine3":"","addressLine4":"","city":"Lodz","postcode":"92-216","country":2031,"countryName":"Poland"},"phone":"48426757371","email":"dominik.strzelecki@umed.lodz.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100018907"},"personInfo":{"id":965793,"firstName":"Dominik","lastName":"Strzelecki","telephone":"48426757371","email":"dominik.strzelecki@umed.lodz.pl"},"departmentName":"Klinika Zaburzeń Afektywnych i Psychotycznych"},{"id":865482,"organisationAddressInfo":{"id":575489,"organisation":{"id":608202,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Centrum Badan Klinicznych Pi-House Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100040967","organisationLocationStatus":"Active"},"address":{"addressId":620302,"oneLine":"Ul. Na Zaspe 3","addressLine1":"Ul. Na Zaspe 3","addressLine2":"","addressLine3":"","addressLine4":"","city":"Gdansk","postcode":"80-546","country":2031,"countryName":"Poland"},"phone":"48587122222","email":"hanna@pihouse.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100040967"},"personInfo":{"id":965791,"firstName":"Hanna","lastName":"Badzio Jagiełło","telephone":"48587122222","email":"hanna@pihouse.pl"},"departmentName":"N/A"},{"id":865481,"organisationAddressInfo":{"id":575486,"organisation":{"id":608199,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Inventiva Biomedical And Research Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100049619","organisationLocationStatus":"Active"},"address":{"addressId":620298,"oneLine":"Ul. Polna 16/20","addressLine1":"Ul. Polna 16/20","addressLine2":"","addressLine3":"","addressLine4":"","city":"Tuszyn","postcode":"95-080","country":2031,"countryName":"Poland"},"phone":"48602305132","email":"jarek35a@hotmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100049619"},"personInfo":{"id":965790,"firstName":"Jarosław","lastName":"Strzelec","telephone":"48602305132","email":"jarek35a@hotmail.com"},"departmentName":"N/A"},{"id":865483,"organisationAddressInfo":{"id":575490,"organisation":{"id":608203,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Instytut Psychiatrii I Neurologii","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100028715","organisationLocationStatus":"Active"},"address":{"addressId":620303,"oneLine":"Ul. Jana III Sobieskiego 9","addressLine1":"Ul. Jana III Sobieskiego 9","addressLine2":"","addressLine3":"","addressLine4":"","city":"Warsaw","postcode":"02-957","country":2031,"countryName":"Poland"},"phone":"48605146486","email":"pokorska@ipin.edu.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100028715"},"personInfo":{"id":965792,"firstName":"Justyna","lastName":"Holka-Pokorska","telephone":"48605146486","email":"pokorska@ipin.edu.pl"},"departmentName":"Zakład Farmakologii i  Fizjologii Układu Nerwowego"},{"id":865480,"organisationAddressInfo":{"id":575478,"organisation":{"id":608190,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Uniwersyteckie Centrum Kliniczne","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042500","organisationLocationStatus":"Active"},"address":{"addressId":620290,"oneLine":"Ul. Mariana Smoluchowskiego 17","addressLine1":"Ul. Mariana Smoluchowskiego 17","addressLine2":"","addressLine3":"","addressLine4":"","city":"Gdansk","postcode":"80-214","country":2031,"countryName":"Poland"},"phone":"48583492650","email":"cubala@gumed.edu.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100042500"},"personInfo":{"id":965789,"firstName":"Wiesław Jerzy","lastName":"Cubała","telephone":"48583492650","email":"cubala@gumed.edu.pl"},"departmentName":"Klinika Psychiatrii  Dorosłych"}],"applicationStatusCode":"Authorised"}],"applicationInfo":[{"id":23566,"type":"INITIAL","status":"Authorised","ctNumber":"2024-513457-70-00","trialStatus":"Ended","submissionDate":"2024-09-11","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-20"},"partIIInfo":[{"id":86913,"mscId":28194,"mscInfo":{"id":28194,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-24","decision":"authorized","decisionDate":"2024-09-26","reportingStatusCode":"Ended","countryName":"Germany","trialStatus":"Ended","firstDecisionDate":"2024-09-26"},"applicationStatusCode":"Authorised"},{"id":86914,"mscId":28195,"mscInfo":{"id":28195,"mscName":"Spain","countryOrganisationId":2027,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-24","decision":"authorized","decisionDate":"2024-09-24","reportingStatusCode":"Ended","countryName":"Spain","trialStatus":"Ended","firstDecisionDate":"2024-09-24"},"applicationStatusCode":"Authorised"},{"id":86915,"mscId":28196,"mscInfo":{"id":28196,"mscName":"Poland","countryOrganisationId":2031,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-24","decision":"authorized","decisionDate":"2024-09-25","reportingStatusCode":"Ended","countryName":"Poland","trialStatus":"Ended","firstDecisionDate":"2024-09-25"},"applicationStatusCode":"Authorised"}],"decisionDate":"2024-09-24","ctMSCsByApplication":[{"id":28194,"mscName":"Germany","reportingStatusCode":"Ended"},{"id":28195,"mscName":"Spain","reportingStatusCode":"Ended"},{"id":28196,"mscName":"Poland","reportingStatusCode":"Ended"}],"businessKey":"IN","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":39303,"applicationId":23566,"mscId":28196,"mscName":"Poland","decisionDate":"2024-09-25T17:38:18.249","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":86915,"part1Id":35052,"applicationType":"INITIAL","isRMS":false},{"id":39011,"applicationId":23566,"mscId":28195,"mscName":"Spain","decisionDate":"2024-09-24T11:42:21.282","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":86914,"part1Id":35052,"applicationType":"INITIAL","isRMS":false},{"id":39443,"applicationId":23566,"mscId":28194,"mscName":"Germany","decisionDate":"2024-09-26T15:33:42.423","decision":"authorized","assessmentOutcome":"acceptable","eventType":"decision","part2Id":86913,"part1Id":35052,"applicationType":"INITIAL","isRMS":true}]},{"id":38201,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2024-513457-70-00","trialStatus":"Ended","submissionDate":"2024-10-17","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-20"},"partIIInfo":[],"decisionDate":"2024-10-17","ctMSCsByApplication":[{"id":28194,"mscName":"Germany","reportingStatusCode":"Ended"},{"id":28195,"mscName":"Spain","reportingStatusCode":"Ended"},{"id":28196,"mscName":"Poland","reportingStatusCode":"Ended"}],"businessKey":"NSM-1","modScope":"PART_I","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":42448,"applicationId":38201,"mscId":28194,"mscName":"Germany","decisionDate":"2024-10-17T15:52:35.683","decision":"authorized","eventType":"decision","part1Id":58650,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":true},{"id":42448,"applicationId":38201,"mscId":28195,"mscName":"Spain","decisionDate":"2024-10-17T15:52:35.683","decision":"authorized","eventType":"decision","part1Id":58650,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":42448,"applicationId":38201,"mscId":28196,"mscName":"Poland","decisionDate":"2024-10-17T15:52:35.683","decision":"authorized","eventType":"decision","part1Id":58650,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}]},{"id":49526,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2024-513457-70-00","trialStatus":"Ended","submissionDate":"2025-03-05","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-20"},"partIIInfo":[],"decisionDate":"2025-03-05","ctMSCsByApplication":[{"id":28194,"mscName":"Germany","reportingStatusCode":"Ended"},{"id":28195,"mscName":"Spain","reportingStatusCode":"Ended"},{"id":28196,"mscName":"Poland","reportingStatusCode":"Ended"}],"businessKey":"NSM-2","modScope":"PART_I","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":60633,"applicationId":49526,"mscId":28194,"mscName":"Germany","decisionDate":"2025-03-05T18:58:06.187","decision":"authorized","eventType":"decision","part1Id":76308,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":true},{"id":60633,"applicationId":49526,"mscId":28195,"mscName":"Spain","decisionDate":"2025-03-05T18:58:06.187","decision":"authorized","eventType":"decision","part1Id":76308,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":60633,"applicationId":49526,"mscId":28196,"mscName":"Poland","decisionDate":"2025-03-05T18:58:06.187","decision":"authorized","eventType":"decision","part1Id":76308,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}]},{"id":51416,"type":"NON SUBSTANTIAL MODIFICATION","status":"Authorised","ctNumber":"2024-513457-70-00","trialStatus":"Ended","submissionDate":"2025-04-15","partI":{"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2024-09-20"},"partIIInfo":[],"decisionDate":"2025-04-15","ctMSCsByApplication":[{"id":28194,"mscName":"Germany","reportingStatusCode":"Ended"},{"id":28195,"mscName":"Spain","reportingStatusCode":"Ended"},{"id":28196,"mscName":"Poland","reportingStatusCode":"Ended"}],"businessKey":"NSM-3","modScope":"PART_I","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":66922,"applicationId":51416,"mscId":28194,"mscName":"Germany","decisionDate":"2025-04-15T10:07:27.871","decision":"authorized","eventType":"decision","part1Id":79231,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":true},{"id":66922,"applicationId":51416,"mscId":28195,"mscName":"Spain","decisionDate":"2025-04-15T10:07:27.871","decision":"authorized","eventType":"decision","part1Id":79231,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false},{"id":66922,"applicationId":51416,"mscId":28196,"mscName":"Poland","decisionDate":"2025-04-15T10:07:27.871","decision":"authorized","eventType":"decision","part1Id":79231,"applicationType":"NON SUBSTANTIAL MODIFICATION","isRMS":false}]}],"trialGlobalEnd":[],"memberStatesConcerned":[{"mscName":"Poland","mscId":28196,"firstDecisionDate":"2024-09-25T17:38:18.249","lastDecisionDate":"2024-09-25T17:38:18.249","mscPublicStatusCode":8},{"mscName":"Spain","mscId":28195,"firstDecisionDate":"2024-09-24T11:42:21.282","lastDecisionDate":"2024-09-24T11:42:21.282","mscPublicStatusCode":8},{"mscName":"Germany","mscId":28194,"firstDecisionDate":"2024-09-26T15:33:42.423","lastDecisionDate":"2024-09-26T15:33:42.423","mscPublicStatusCode":8}],"eudraCt":{"isTransitioned":true,"eudraCtCode":"2022-003743-10"}},"events":{"temporaryHaltList":[],"trialEvents":[{"mscId":28194,"mscName":"Germany","events":[{"notificationType":"START_OF_TRIAL","date":"2023-11-07"},{"notificationType":"END_OF_TRIAL","date":"2025-07-03"},{"notificationType":"START_OF_RECRUITMENT","date":"2023-11-27"},{"notificationType":"END_OF_RECRUITMENT","date":"2025-01-31"}]},{"mscId":28195,"mscName":"Spain","events":[{"notificationType":"START_OF_TRIAL","date":"2023-10-24"},{"notificationType":"END_OF_TRIAL","date":"2025-06-18"},{"notificationType":"START_OF_RECRUITMENT","date":"2024-01-17"},{"notificationType":"END_OF_RECRUITMENT","date":"2025-01-31"}]},{"mscId":28196,"mscName":"Poland","events":[{"notificationType":"START_OF_TRIAL","date":"2023-09-08"},{"notificationType":"END_OF_TRIAL","date":"2025-06-26"},{"notificationType":"START_OF_RECRUITMENT","date":"2023-09-22"},{"notificationType":"END_OF_RECRUITMENT","date":"2025-01-31"}]}],"trialGlobalEndDate":"2025-07-04","unexpectedEvents":[],"seriousBreaches":[],"urgentSafetyMeasures":[]},"results":{"summaryResults":[{"id":7010,"ctNumber":"2024-513457-70-00","title":"Final Summary of results_2024-513457-70-00_Public","status":"Submitted","summaryType":"Summary of Results","versionType":"Final","isFinalResult":true,"notificationId":141890,"updatedOn":"2026-07-03T12:18:50.962227","createdOn":"2026-07-03T12:11:45.532","submissionDate":"2026-07-03T12:18:50","ctId":14288,"businessKey":"SUM-141508"}],"laypersonResults":[{"id":7008,"ctNumber":"2024-513457-70-00","title":"Lay Summary of results_2024-513457-70-00","status":"Submitted","summaryType":"Laypersons Summary of Results","versionType":"Final","isFinalResult":true,"notificationId":141880,"updatedOn":"2026-07-03T12:19:02.555677","createdOn":"2026-07-03T11:47:40.983","submissionDate":"2026-07-03T12:19:02","ctId":14288,"businessKey":"SUM-141489"}]},"documents":[{"title":"K1_Recruitment arrangements_blank doc","uuid":"d03d1792-0db3-42c3-a655-ccebacc18f11","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86913,"manualVersion":"NA","systemVersion":"1"},{"title":"L1_SIS and ICF_Main_CORE_de_Redacted","uuid":"ae60611f-7fd8-4cca-ac68-e3d06612bc4b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":86913,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Pregnant_Partner_de_Public","uuid":"be79b3f3-0c04-4ad7-a8ff-c9da533bf4fb","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":86913,"manualVersion":"1.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main_CORE_en_Redacted","uuid":"4e1fdfb0-6852-4397-b4a9-c1532bf52b27","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86913,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Pregnancy_FUP_de_Public","uuid":"eaaf9dc7-d0e2-427b-8cfa-a67faa37daca","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":86913,"manualVersion":"1.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main_OLE_en_Redacted","uuid":"cc78b033-194c-44d5-917e-3a0568e95142","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86913,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main_OLE_de_Redacted","uuid":"332aa087-6a8f-40af-8e56-ae54377d7d6f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":4,"fileType":"PDF","associatedEntityId":86913,"manualVersion":"4.1","systemVersion":"1"},{"title":"K1_ Recruitment arrangements_blank doc","uuid":"df9ac528-b9d8-430e-bf90-1bd107a7b76c","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86914,"manualVersion":"N/A","systemVersion":"1"},{"title":"L1_SIS and ICF_Pregnant_Partner_Public","uuid":"d40ab2ac-6f8a-4279-bd8e-acb09888106f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":86914,"manualVersion":"1.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main Subject CORE_eng_Redacted","uuid":"60e9c39e-03f9-4aa7-8cb2-772da39c8c1b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86914,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main Subject CORE_spa_Redacted","uuid":"8449dfcc-b371-43ad-b35d-3441da72d6a9","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":86914,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main Subject OLE_eng_Redacted","uuid":"93eb1c73-36ba-4d02-9145-b488261c6ef5","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86914,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main Subject OLE_spa_Redacted","uuid":"a39e8a9a-6264-44cf-a079-621448f58bd9","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":86914,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF_PregnancyFollow-up_Public","uuid":"5546c8a2-1160-4d2f-8ab7-13e786368b9b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":86914,"manualVersion":"1.1","systemVersion":"1"},{"title":"K1_Recruitment arrangements_blank doc","uuid":"5dac6a67-72ed-48c5-90fb-4135b0e4de0e","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86915,"manualVersion":"N/A","systemVersion":"1"},{"title":"L1_SIS and ICF Pregnancy_Follow-up_Redacted","uuid":"e72775ca-fcf3-4ed2-a0e3-c7afb913af36","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":86915,"manualVersion":"1.1","systemVersion":"1"},{"title":"L1_SIS and ICF Pregnant_Partner_Redacted","uuid":"0ea4c774-ee7d-4220-ba46-815af245c09b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":86915,"manualVersion":"1.1","systemVersion":"1"},{"title":"L1_SIS and ICF main subject core_PL_Redacted","uuid":"d280e54e-feef-43f6-b562-febf6314b8fa","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":86915,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF main subject ole_EN_Redacted","uuid":"db282197-2b7a-41e4-9070-d1f1f51b0e92","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86915,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF main subject ole_PL_Redacted","uuid":"c4c1c3c4-36ba-4d2e-8f3e-a1fee1625f3c","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":86915,"manualVersion":"4.1","systemVersion":"1"},{"title":"L1_SIS and ICF main subject core_EN_Redacted","uuid":"65bc0ab2-3a8a-494a-9f57-61b80a6937f6","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":86915,"manualVersion":"4.1","systemVersion":"1"},{"title":"D1_Protocol_2024-513457-70-00_redacted","uuid":"768c1e0c-acf5-4a6a-b4b7-6b0b949aa383","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":79231,"manualVersion":"3.0","systemVersion":"1"},{"title":"D1_Protocol_synopsis_DE 2024-513457-70-00_redacted","uuid":"48ac12de-cc97-4c20-9a5c-9b6c5c45f825","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":79231,"manualVersion":"3.0","systemVersion":"1"},{"title":"D1_Protocol_synopsis_EN 2024-513457-70-00_redacted","uuid":"76ec30dc-9425-4b5e-9353-0569b0cd4736","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":79231,"manualVersion":"3.0","systemVersion":"1"},{"title":"D1_Protocol_synopsis_ES 2024-513457-70-00_redacted","uuid":"d840523d-6cb8-493e-85c9-e259ca358aa2","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":79231,"manualVersion":"3.0","systemVersion":"1"},{"title":"D1_Protocol_synopsis_PO 2024-513457-70-00_redacted","uuid":"99e7bc8d-cfeb-4e89-a296-99987f829b7a","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":79231,"manualVersion":"3.0","systemVersion":"1"},{"title":"Lay Summary of results_2024-513457-70-00_Public_po","uuid":"10b70d24-6f4d-42ed-b728-3bc1f5fd97a9","documentType":"46","documentTypeLabel":"Laypersons summary of results (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":7008,"manualVersion":"1.0","systemVersion":"1"},{"title":"Lay Summary of results_2024-513457-70-00_Public_en","uuid":"c90eccd3-5b02-4b0b-ad72-4c017bb82890","documentType":"46","documentTypeLabel":"Laypersons summary of results (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":7008,"manualVersion":"1.0","systemVersion":"1"},{"title":"Lay Summary of results_2024-513457-70-00_Public_es","uuid":"1451bfab-56f8-4934-879a-8fc22c64d224","documentType":"46","documentTypeLabel":"Laypersons summary of results (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":7008,"manualVersion":"1.0","systemVersion":"1"},{"title":"Lay Summary of results_2024-513457-70-00_Public_de","uuid":"df1b00fa-d3e8-438d-8f58-a80e2cb1d6ae","documentType":"46","documentTypeLabel":"Laypersons summary of results (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":7008,"manualVersion":"1.0","systemVersion":"1"},{"title":"Summary of results_2024-513457-70-00_Public","uuid":"a2f8ee41-b221-4488-a1a3-02d9d0253e20","documentType":"103","documentTypeLabel":"Summary of results (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":7010,"manualVersion":"1.0","systemVersion":"1"}],"trialRegion":"Both","trialRegionCode":3,"correctiveMeasures":[]}