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depression","fullTitleTranslations":[{"id":11347152,"uuid":"249bc266-3666-492c-88da-a0af8f036884","attributeTranslation":"Estudio en fase III, multicéntrico, controlado, aleatorizado y con enmascaramiento doble para investigar la eficacia, la seguridad y la tolerabilidad de dos administraciones iniciales de COMP360 en participantes que sufren depresión resistente al tratamiento","language":7,"languageDescription":"Spanish"},{"id":11347151,"uuid":"249bc266-3666-492c-88da-a0af8f036884","attributeTranslation":"Étude de phase III, multicentrique, randomisée, menée en double aveugle et contrôlée visant à évaluer l'efficacité, la sécurité d’emploi et la tolérance de deux administrations de COMP360 chez des patients atteints de dépression résistante au traitement","language":10,"languageDescription":"French"},{"id":11347150,"uuid":"249bc266-3666-492c-88da-a0af8f036884","attributeTranslation":"Wieloośrodkowe, randomizowane, prowadzone metodą podwójnie ślepej próby, z grupą kontrolną, badanie fazy III oceniające skuteczność, bezpieczeństwo stosowania i tolerancję dwukrotnego podania COMP360 u uczestników z depresją lekooporną","language":19,"languageDescription":"Polish"},{"id":11347149,"uuid":"249bc266-3666-492c-88da-a0af8f036884","attributeTranslation":"Een multicenter, gerandomiseerd, dubbelblind, gecontroleerd fase 3-onderzoek naar de werkzaamheid, veiligheid \nen verdraagbaarheid van twee initiële toedieningen van COMP360 aan deelnemers met behandelingsresistente depressie","language":37,"languageDescription":"Dutch (Netherlands)"}],"publicTitle":"A Phase III study to investigate two initial administrations of COMP360 in treatment-resistant depression","publicTitleTranslations":[{"id":11347185,"uuid":"22266766-3e4d-43c9-a8a7-ef0c02614d4f","attributeTranslation":"Een fase 3-onderzoek naar twee initiële toedieningen van COMP360 bij behandelingsresistente depressie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347186,"uuid":"22266766-3e4d-43c9-a8a7-ef0c02614d4f","attributeTranslation":"Un estudio en fase III para investigar dos administraciones iniciales de COMP360 en la depresión resistente al tratamiento","language":7,"languageDescription":"Spanish"},{"id":11347187,"uuid":"22266766-3e4d-43c9-a8a7-ef0c02614d4f","attributeTranslation":"Badanie fazy III mające na celu zbadanie wstępnego dwukrotnego podania COMP360 w depresji lekoopornej","language":19,"languageDescription":"Polish"},{"id":11347188,"uuid":"22266766-3e4d-43c9-a8a7-ef0c02614d4f","attributeTranslation":"Étude de phase III visant à évaluer deux administrations initiales de COMP360 en cas de dépression résistante au traitement","language":10,"languageDescription":"French"}],"shortTitle":"COMP 006","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"This is a Phase III study and is categorised as Category 2 as per EMA guidance.","trialCategoryId":124701},"medicalCondition":{"partIMedicalConditions":[{"id":141362,"medicalCondition":"Treatment-resistant depression","medicalConditionTranslations":[{"id":11347063,"uuid":"59b79c85-541e-4204-927c-35c42d4ed21a","attributeTranslation":"Depresja lekooporna","language":19,"languageDescription":"Polish"},{"id":11347061,"uuid":"59b79c85-541e-4204-927c-35c42d4ed21a","attributeTranslation":"Dépression résistante au traitement","language":10,"languageDescription":"French"},{"id":11347064,"uuid":"59b79c85-541e-4204-927c-35c42d4ed21a","attributeTranslation":"Behandelingsresistente depressie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347062,"uuid":"59b79c85-541e-4204-927c-35c42d4ed21a","attributeTranslation":"Depresión resistente al 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przesiewowych","language":19,"languageDescription":"Polish"},{"id":11347156,"uuid":"d9bbeb4a-988e-481e-963f-f37612f8e4fe","attributeTranslation":"Âge égal ou supérieur à 18 ans à la sélection","language":10,"languageDescription":"French"}]},{"id":918163,"number":2,"principalInclusionCriteria":"Major depression without psychotic features","principalInclusionCriteriaTranslations":[{"id":11347160,"uuid":"dc680fdb-96b3-4886-9537-94163814a20a","attributeTranslation":"Dépression majeure sans symptômes psychotiques","language":10,"languageDescription":"French"},{"id":11347157,"uuid":"dc680fdb-96b3-4886-9537-94163814a20a","attributeTranslation":"Depresja duża bez cech psychotycznych","language":19,"languageDescription":"Polish"},{"id":11347159,"uuid":"dc680fdb-96b3-4886-9537-94163814a20a","attributeTranslation":"Ernstige depressie zonder psychotische kenmerken","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347158,"uuid":"dc680fdb-96b3-4886-9537-94163814a20a","attributeTranslation":"Depresión mayor sin características psicóticas","language":7,"languageDescription":"Spanish"}]},{"id":918164,"number":3,"principalInclusionCriteria":"If the current major depressive episode is the participant’s first lifetime episode of depression, the length of the current episode must be ≥6 months and ≤2 years at Screening","principalInclusionCriteriaTranslations":[{"id":11347164,"uuid":"03000cf1-7bd1-4637-8764-a6e4ac511a8a","attributeTranslation":"Jeśli obecny epizod depresji dużej jest pierwszym epizodem depresji w ciągu całego życia uczestnika, czas trwania obecnego epizodu musi wynosić ≥ 6 miesięcy, ale ≤ 2 lat do chwili przeprowadzenia badań przesiewowych","language":19,"languageDescription":"Polish"},{"id":11347161,"uuid":"03000cf1-7bd1-4637-8764-a6e4ac511a8a","attributeTranslation":"Si el episodio de depresión mayor actual es el primero en la vida del participante, su duración debe ser de ≥6 meses a ≤2 años en el momento de la selección","language":7,"languageDescription":"Spanish"},{"id":11347163,"uuid":"03000cf1-7bd1-4637-8764-a6e4ac511a8a","attributeTranslation":"Als de huidige episode van zware depressie de eerste episode van depressie in het leven van de deelnemer is, moet de duur van de huidige episode ≥ 6 maanden zijn en ≤ 2 jaar bij screening","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347162,"uuid":"03000cf1-7bd1-4637-8764-a6e4ac511a8a","attributeTranslation":"Si l’épisode dépressif majeur en cours est le premier épisode de dépression de toute la vie du participant, la durée de l’épisode actuel doit être ≥ 6 mois et ≤ 2 ans à la sélection","language":10,"languageDescription":"French"}]},{"id":918165,"number":4,"principalInclusionCriteria":"MADRS total score ≥20 at Screening and Baseline","principalInclusionCriteriaTranslations":[{"id":11347168,"uuid":"31a68f59-7695-40df-9b12-de09b3b20aa7","attributeTranslation":"Puntuación total ≥20 en la escala MADRS","language":7,"languageDescription":"Spanish"},{"id":11347167,"uuid":"31a68f59-7695-40df-9b12-de09b3b20aa7","attributeTranslation":"MADRS totaalscore ≥ 20 bij screening en baseline","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347166,"uuid":"31a68f59-7695-40df-9b12-de09b3b20aa7","attributeTranslation":"Score total à l'échelle MADRS ≥ 20","language":10,"languageDescription":"French"},{"id":11347165,"uuid":"31a68f59-7695-40df-9b12-de09b3b20aa7","attributeTranslation":"Wynik całkowity wg skali MADRS wynoszący ≥ 20 podczas badań przesiewowych i w punkcie początkowym","language":19,"languageDescription":"Polish"}]},{"id":918166,"number":5,"principalInclusionCriteria":"TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode","principalInclusionCriteriaTranslations":[{"id":11347170,"uuid":"18eb12a2-1d18-42f3-b66b-aa01ad818323","attributeTranslation":"TRD, gedefinieerd als falende respons op een adequate dosis en duur van twee, drie of vier verschillende farmacologische behandelingen bij de huidige episode","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347172,"uuid":"18eb12a2-1d18-42f3-b66b-aa01ad818323","attributeTranslation":"DRT, définie comme une absence de réponse à une dose et une durée adéquates de deux, trois ou quatre traitements pharmacologiques différents pour l’épisode actuel","language":10,"languageDescription":"French"},{"id":11347171,"uuid":"18eb12a2-1d18-42f3-b66b-aa01ad818323","attributeTranslation":"DRT, que se define como la falta de respuesta a 2, 3 o 4 tratamientos farmacológicos diferentes con una dosis y duración adecuadas para el episodio actual","language":7,"languageDescription":"Spanish"},{"id":11347169,"uuid":"18eb12a2-1d18-42f3-b66b-aa01ad818323","attributeTranslation":"Depresja lekooporna, definiowana jako brak odpowiedzi na odpowiednią dawkę oraz czas trwania dwóch, trzech lub czterech różnych terapii farmakologicznych stosowanych podczas obecnego epizodu","language":19,"languageDescription":"Polish"}]},{"id":918167,"number":6,"principalInclusionCriteria":"Successful discontinuation of all prohibited medications at least two weeks prior to the Baseline visit (if applicable)","principalInclusionCriteriaTranslations":[{"id":11347173,"uuid":"e9fba281-56bb-4928-b487-650f6724a3d0","attributeTranslation":"Arrêt réussi de tous les médicaments interdits au moins deux semaines avant la visite d’inclusion (le cas échéant)","language":10,"languageDescription":"French"},{"id":11347176,"uuid":"e9fba281-56bb-4928-b487-650f6724a3d0","attributeTranslation":"Succesvolle stopzetting van alle verboden medicatie ten minste twee weken voorafgaand aan het baselinebezoek (indien van toepassing)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347175,"uuid":"e9fba281-56bb-4928-b487-650f6724a3d0","attributeTranslation":"La interrupción satisfactoria de todos los medicamentos prohibidos al menos dos semanas antes de la visita inicial (cuando corresponda)","language":7,"languageDescription":"Spanish"},{"id":11347174,"uuid":"e9fba281-56bb-4928-b487-650f6724a3d0","attributeTranslation":"Skuteczne odstawienie wszystkich zabronionych leków co najmniej dwa tygodnie przed wizytą początkową (w stosownych przypadkach)","language":19,"languageDescription":"Polish"}]},{"id":918168,"number":7,"principalInclusionCriteria":"Please refer to the Protocol for the full list of inclusion criteria","principalInclusionCriteriaTranslations":[{"id":11347179,"uuid":"b5a4ef91-dc47-4dbb-baeb-e1f250937d8e","attributeTranslation":"Veuillez consulter la liste complète des critères d'inclusion dans le protocole","language":10,"languageDescription":"French"},{"id":11347178,"uuid":"b5a4ef91-dc47-4dbb-baeb-e1f250937d8e","attributeTranslation":"Pełną listę kryteriów włączenia można znaleźć w protokole","language":19,"languageDescription":"Polish"},{"id":11347180,"uuid":"b5a4ef91-dc47-4dbb-baeb-e1f250937d8e","attributeTranslation":"Encontrará la lista completa de criterios de inclusión en el Protocolo","language":7,"languageDescription":"Spanish"},{"id":11347177,"uuid":"b5a4ef91-dc47-4dbb-baeb-e1f250937d8e","attributeTranslation":"Raadpleeg het protocol voor de volledige lijst met insluitingscriteria","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"principalExclusionCriteria":[{"id":1569564,"number":1,"principalExclusionCriteria":"Prior or ongoing bipolar disorder, any psychotic disorder, or antisocial personality disorder","principalExclusionCriteriaTranslations":[{"id":11347072,"uuid":"0394173e-719f-4f7a-8087-ad1f9155c97a","attributeTranslation":"Trouble bipolaire antérieur ou actuel, tout trouble psychotique ou trouble de la personnalité antisociale","language":10,"languageDescription":"French"},{"id":11347069,"uuid":"0394173e-719f-4f7a-8087-ad1f9155c97a","attributeTranslation":"Wcześniejsze lub trwające obecnie zaburzenie afektywne dwubiegunowe, dowolne zaburzenia psychotyczne lub antyspołeczne zaburzenie osobowości","language":19,"languageDescription":"Polish"},{"id":11347070,"uuid":"0394173e-719f-4f7a-8087-ad1f9155c97a","attributeTranslation":"Eerdere of voortgaande bipolaire stoornis, psychotische stoornis of antisociale persoonlijkheidsstoornis","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347071,"uuid":"0394173e-719f-4f7a-8087-ad1f9155c97a","attributeTranslation":"Trastorno bipolar previo o persistente, cualquier trastorno psicótico o trastorno de personalidad antisocial","language":7,"languageDescription":"Spanish"}]},{"id":1569565,"number":10,"principalExclusionCriteria":"Clinically significant results on vital signs, ECG, or physical examination at Screening or Baseline, or laboratory tests at Screening","principalExclusionCriteriaTranslations":[{"id":11347074,"uuid":"11323f22-58e0-42ef-af07-50d30e539edb","attributeTranslation":"Resultados significativos a nivel clínico en las constantes vitales, el ECG o la exploración física en la selección o en el periodo inicial, o en las pruebas analíticas de la selección","language":7,"languageDescription":"Spanish"},{"id":11347076,"uuid":"11323f22-58e0-42ef-af07-50d30e539edb","attributeTranslation":"Klinicznie istotne parametry życiowe, wyniki badania EKG lub badania przedmiotowego uzyskane podczas badań przesiewowych lub w punkcie początkowym, albo wyniki testów laboratoryjnych uzyskane podczas badań przesiewowych","language":19,"languageDescription":"Polish"},{"id":11347073,"uuid":"11323f22-58e0-42ef-af07-50d30e539edb","attributeTranslation":"Résultats cliniquement significatifs concernant les signes vitaux, l’ECG ou l’examen clinique à la sélection ou à l’inclusion, ou les analyses biologiques à la sélection","language":10,"languageDescription":"French"},{"id":11347075,"uuid":"11323f22-58e0-42ef-af07-50d30e539edb","attributeTranslation":"Klinisch significante resultaten op vitale functies, ECG of lichamelijk onderzoek bij screening of baseline, of op laboratoriumtests bij screening","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1569566,"number":11,"principalExclusionCriteria":"Please refer to the Protocol for the full list of exclusion criteria","principalExclusionCriteriaTranslations":[{"id":11347080,"uuid":"be3da904-247a-49a2-ae67-d6981a66ca49","attributeTranslation":"Pełną listę kryteriów wyłączenia można znaleźć w protokole","language":19,"languageDescription":"Polish"},{"id":11347079,"uuid":"be3da904-247a-49a2-ae67-d6981a66ca49","attributeTranslation":"Raadpleeg het protocol voor de volledige lijst met uitsluitingscriteria","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347078,"uuid":"be3da904-247a-49a2-ae67-d6981a66ca49","attributeTranslation":"Veuillez consulter la liste complète des critères de non-inclusion dans le protocole","language":10,"languageDescription":"French"},{"id":11347077,"uuid":"be3da904-247a-49a2-ae67-d6981a66ca49","attributeTranslation":"Puede consultar en el Protocolo la lista completa de criterios de exclusión","language":7,"languageDescription":"Spanish"}]},{"id":1569567,"number":12,"principalExclusionCriteria":"Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity","principalExclusionCriteriaTranslations":[{"id":11347082,"uuid":"8af8900c-67ef-4646-a557-79a0585cb20b","attributeTranslation":"Trwające całe życie paranoiczne, schizoidalne, schizotypowe, histrioniczne, narcystyczne zaburzenia osobowości lub dowolne występujące obecnie ciężkie współistniejące zaburzenie psychiczne","language":19,"languageDescription":"Polish"},{"id":11347081,"uuid":"8af8900c-67ef-4646-a557-79a0585cb20b","attributeTranslation":"Troubles de la personnalité paranoïde, schizoïde, schizotypique, histrionique, narcissique à vie ou toute comorbidité psychiatrique grave actuelle","language":10,"languageDescription":"French"},{"id":11347084,"uuid":"8af8900c-67ef-4646-a557-79a0585cb20b","attributeTranslation":"Trastorno de personalidad paranoide, esquizoide, esquizotípico, histriónico o narcisista permanente, o cualquier comorbilidad psiquiátrica grave y persistente","language":7,"languageDescription":"Spanish"},{"id":11347083,"uuid":"8af8900c-67ef-4646-a557-79a0585cb20b","attributeTranslation":"Levenslange blootstelling aan psychedelica met therapeutische bedoelingen","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1569568,"number":13,"principalExclusionCriteria":"Borderline personality disorder","principalExclusionCriteriaTranslations":[{"id":11347087,"uuid":"13e1c132-8c8b-444c-85be-87c4982243bd","attributeTranslation":"Borderline persoonlijkheidsstoornis","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347088,"uuid":"13e1c132-8c8b-444c-85be-87c4982243bd","attributeTranslation":"Trouble de la personnalité borderline","language":10,"languageDescription":"French"},{"id":11347085,"uuid":"13e1c132-8c8b-444c-85be-87c4982243bd","attributeTranslation":"Zaburzenia osobowości typu borderline","language":19,"languageDescription":"Polish"},{"id":11347086,"uuid":"13e1c132-8c8b-444c-85be-87c4982243bd","attributeTranslation":"Trastorno límite de la personalidad","language":7,"languageDescription":"Spanish"}]},{"id":1569569,"number":14,"principalExclusionCriteria":"Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa","principalExclusionCriteriaTranslations":[{"id":11347090,"uuid":"fabee30a-2859-43f7-88b6-eadb2923cafc","attributeTranslation":"Voortgaande posttraumatische stressstoornis, obsessief-compulsieve stoornis of anorexia nervosa","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347089,"uuid":"fabee30a-2859-43f7-88b6-eadb2923cafc","attributeTranslation":"Trastorno por estrés postraumático persistente, trastorno obsesivo compulsivo o anorexia nerviosa","language":7,"languageDescription":"Spanish"},{"id":11347092,"uuid":"fabee30a-2859-43f7-88b6-eadb2923cafc","attributeTranslation":"Trouble de stress post-traumatique en cours, trouble obsessionnel compulsif ou anorexie mentale","language":10,"languageDescription":"French"},{"id":11347091,"uuid":"fabee30a-2859-43f7-88b6-eadb2923cafc","attributeTranslation":"Występujące obecnie zaburzenia stresu pourazowego, zaburzenia obsesyjno-kompulsyjne lub jadłowstręt psychiczny","language":19,"languageDescription":"Polish"}]},{"id":1569570,"number":15,"principalExclusionCriteria":"Psychiatric inpatient within the past six months prior to Screening","principalExclusionCriteriaTranslations":[{"id":11347095,"uuid":"e99ac8e1-a7ce-4bc7-8b3b-d30b3ca8da5c","attributeTranslation":"Hospitalización psiquiátrica en los 6 meses previos a la selección","language":7,"languageDescription":"Spanish"},{"id":11347093,"uuid":"e99ac8e1-a7ce-4bc7-8b3b-d30b3ca8da5c","attributeTranslation":"Hospitalizacja pacjenta na oddziale psychiatrycznym w okresie ostatnich sześciu miesięcy przed badaniami przesiewowymi","language":19,"languageDescription":"Polish"},{"id":11347096,"uuid":"e99ac8e1-a7ce-4bc7-8b3b-d30b3ca8da5c","attributeTranslation":"Hospitalisation psychiatrique au cours des six mois précédant la sélection","language":10,"languageDescription":"French"},{"id":11347094,"uuid":"e99ac8e1-a7ce-4bc7-8b3b-d30b3ca8da5c","attributeTranslation":"Psychiatrische opname in de afgelopen zes maanden voorafgaand aan de screening","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1569571,"number":16,"principalExclusionCriteria":"Use of all invasive somatic treatments during the current depressive episode","principalExclusionCriteriaTranslations":[{"id":11347100,"uuid":"af4bf5a6-ab40-46bc-b68e-51eafe7c1adf","attributeTranslation":"Stosowanie każdej inwazyjnej metody leczenia somatycznego w czasie trwania obecnego epizodu depresji","language":19,"languageDescription":"Polish"},{"id":11347099,"uuid":"af4bf5a6-ab40-46bc-b68e-51eafe7c1adf","attributeTranslation":"Gebruik van alle invasieve somatische behandelingen tijdens de huidige depressieve episode","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347097,"uuid":"af4bf5a6-ab40-46bc-b68e-51eafe7c1adf","attributeTranslation":"Utilisation de tous les traitements somatiques invasifs au cours de l'épisode actuel de dépression","language":10,"languageDescription":"French"},{"id":11347098,"uuid":"af4bf5a6-ab40-46bc-b68e-51eafe7c1adf","attributeTranslation":"Uso de todos los tratamientos somáticos invasivos durante el episodio depresivo actual","language":7,"languageDescription":"Spanish"}]},{"id":1569572,"number":17,"principalExclusionCriteria":"Use of all non invasive somatic treatments within the past six months prior to Screening","principalExclusionCriteriaTranslations":[{"id":11347104,"uuid":"5a0b7638-be6b-4d7b-a543-4b50317ee302","attributeTranslation":"Utilisation de tous les traitements somatiques non invasifs au cours des six derniers mois précédant la sélection","language":10,"languageDescription":"French"},{"id":11347103,"uuid":"5a0b7638-be6b-4d7b-a543-4b50317ee302","attributeTranslation":"Stosowanie każdej nieinwazyjnej metody leczenia somatycznego w okresie ostatnich sześciu miesięcy przed badaniami przesiewowymi","language":19,"languageDescription":"Polish"},{"id":11347102,"uuid":"5a0b7638-be6b-4d7b-a543-4b50317ee302","attributeTranslation":"Gebruik van alle niet-invasieve somatische behandelingen in de afgelopen zes maanden voorafgaand aan de screening","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347101,"uuid":"5a0b7638-be6b-4d7b-a543-4b50317ee302","attributeTranslation":"Uso de todos los tratamientos somáticos no invasivos durante los seis meses previos a la selección","language":7,"languageDescription":"Spanish"}]},{"id":1569573,"number":18,"principalExclusionCriteria":"Current enrolment in a psychological therapy programme that will not remain stable","principalExclusionCriteriaTranslations":[{"id":11347106,"uuid":"59b52dd6-3aca-49bf-bcb0-f7458569d7fa","attributeTranslation":"Participation actuelle à un programme de thérapie psychologique qui ne restera pas stable","language":10,"languageDescription":"French"},{"id":11347108,"uuid":"59b52dd6-3aca-49bf-bcb0-f7458569d7fa","attributeTranslation":"Obecny udział w programie terapii psychologicznej, która nie pozostanie stabilna","language":19,"languageDescription":"Polish"},{"id":11347107,"uuid":"59b52dd6-3aca-49bf-bcb0-f7458569d7fa","attributeTranslation":"Inscripción actual en un programa de terapia psicológica que no vaya a permanecer estable","language":7,"languageDescription":"Spanish"},{"id":11347105,"uuid":"59b52dd6-3aca-49bf-bcb0-f7458569d7fa","attributeTranslation":"Huidige inschrijving in een psychologisch therapieprogramma dat niet stabiel zal blijven","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1569574,"number":19,"principalExclusionCriteria":"Alcohol or substance use disorder within the 12 months prior to Screening","principalExclusionCriteriaTranslations":[{"id":11347110,"uuid":"35330743-c8b1-4423-8746-a965e541b271","attributeTranslation":"Troubles liés à l’usage d’alcool ou de substances dans les 12 mois précédant la sélection","language":10,"languageDescription":"French"},{"id":11347112,"uuid":"35330743-c8b1-4423-8746-a965e541b271","attributeTranslation":"Stoornis in alcohol- of middelengebruik binnen 12 maanden voorafgaand aan de screening","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347111,"uuid":"35330743-c8b1-4423-8746-a965e541b271","attributeTranslation":"Zaburzenia związane z nadużywaniem alkoholu lub stosowaniem substancji odurzających w okresie 12 miesięcy przed badaniami przesiewowymi","language":19,"languageDescription":"Polish"},{"id":11347109,"uuid":"35330743-c8b1-4423-8746-a965e541b271","attributeTranslation":"Trastorno por consumo de sustancias o alcohol en los 12 meses previos a la selección","language":7,"languageDescription":"Spanish"}]},{"id":1569575,"number":2,"principalExclusionCriteria":"Exhibiting significant suicide risk","principalExclusionCriteriaTranslations":[{"id":11347115,"uuid":"4e8e27a2-33b3-4548-bde7-6bb319b499cc","attributeTranslation":"Presentación de riesgo de suicidio importante","language":7,"languageDescription":"Spanish"},{"id":11347116,"uuid":"4e8e27a2-33b3-4548-bde7-6bb319b499cc","attributeTranslation":"Présence d'un risque suicidaire significatif","language":10,"languageDescription":"French"},{"id":11347113,"uuid":"4e8e27a2-33b3-4548-bde7-6bb319b499cc","attributeTranslation":"Aanwezigheid van aanzienlijk suïciderisico","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347114,"uuid":"4e8e27a2-33b3-4548-bde7-6bb319b499cc","attributeTranslation":"Poważne ryzyko popełnienia samobójstwa u uczestnika","language":19,"languageDescription":"Polish"}]},{"id":1569576,"number":20,"principalExclusionCriteria":"Lifetime exposure to psychedelics with therapeutic intent.","principalExclusionCriteriaTranslations":[{"id":11347119,"uuid":"66b25269-141d-4bef-8a81-3b25ead8388c","attributeTranslation":"Exposition à vie à des agents psychédéliques dans un but thérapeutique.","language":10,"languageDescription":"French"},{"id":11347118,"uuid":"66b25269-141d-4bef-8a81-3b25ead8388c","attributeTranslation":"Levenslange blootstelling aan psychedelica met therapeutische bedoelingen","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347120,"uuid":"66b25269-141d-4bef-8a81-3b25ead8388c","attributeTranslation":"Exposición de por vida a sustancias psicodélicas con intención terapéutica.","language":7,"languageDescription":"Spanish"},{"id":11347117,"uuid":"66b25269-141d-4bef-8a81-3b25ead8388c","attributeTranslation":"Trwająca całe życie ekspozycja na środki psychodeliczne stosowane z zamiarem terapeutycznym","language":19,"languageDescription":"Polish"}]},{"id":1569577,"number":3,"principalExclusionCriteria":"Depression secondary to a medical or drug-related cause in the opinion of the Investigator","principalExclusionCriteriaTranslations":[{"id":11347124,"uuid":"0870ea51-1b90-4771-bc86-6a39f1a5ee24","attributeTranslation":"Dépression secondaire à un état médical ou liée à un médicament selon l’avis de l’investigateur","language":10,"languageDescription":"French"},{"id":11347121,"uuid":"0870ea51-1b90-4771-bc86-6a39f1a5ee24","attributeTranslation":"Depresja wtórna w przebiegu występowania przyczyny natury medycznej lub związanej ze stosowaniem leku w opinii Badacza","language":19,"languageDescription":"Polish"},{"id":11347123,"uuid":"0870ea51-1b90-4771-bc86-6a39f1a5ee24","attributeTranslation":"Depressie secundair aan een medische of drugsgerelateerde oorzaak naar het oordeel van de onderzoeker","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347122,"uuid":"0870ea51-1b90-4771-bc86-6a39f1a5ee24","attributeTranslation":"Depresión que, según el criterio del investigador, esté asociada a una causa médica o farmacológica","language":7,"languageDescription":"Spanish"}]},{"id":1569578,"number":4,"principalExclusionCriteria":"Exposure to psilocybin, or any other classic psychedelics during the past year or current depressive episode, and agreement not to use psychedelics for the duration of the study follow up","principalExclusionCriteriaTranslations":[{"id":11347126,"uuid":"9c53e2b2-4fbf-4f00-8f15-747c153e8be3","attributeTranslation":"Exposition à la psilocybine, ou à tout autre agent psychédélique dit « classique » au cours de la dernière année ou de l’épisode dépressif actuel, et accord du participant de ne pas consommer d’agent psychédélique pendant la durée du suivi de l’étude","language":10,"languageDescription":"French"},{"id":11347128,"uuid":"9c53e2b2-4fbf-4f00-8f15-747c153e8be3","attributeTranslation":"Ekspozycja na psylocybinę lub inne klasyczne środki psychodeliczne w okresie ostatniego roku lub w czasie trwania obecnego epizodu depresji oraz zobowiązanie się do niestosowania środków psychodelicznych przez cały okres obserwacji kontrolnej po badaniu","language":19,"languageDescription":"Polish"},{"id":11347127,"uuid":"9c53e2b2-4fbf-4f00-8f15-747c153e8be3","attributeTranslation":"Blootstelling aan psilocybine of andere klassieke psychedelica in het afgelopen jaar of de huidige depressieve episode, en akkoord om geen psychedelica te gebruiken gedurende de follow-up van het onderzoek","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347125,"uuid":"9c53e2b2-4fbf-4f00-8f15-747c153e8be3","attributeTranslation":"Exposición a la psilocibina o cualquier otra sustancia psicodélica clásica durante el último año o el episodio depresivo actual y haber aceptado no usar sustancias psicodélicas durante el seguimiento del estudio","language":7,"languageDescription":"Spanish"}]},{"id":1569579,"number":5,"principalExclusionCriteria":"Participants who are pregnant, nursing, or planning a pregnancy","principalExclusionCriteriaTranslations":[{"id":11347132,"uuid":"247ee731-2bed-4de9-b169-b2d36277b21c","attributeTranslation":"Deelnemers die zwanger zijn, borstvoeding geven of van plan zijn zwanger te worden","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347130,"uuid":"247ee731-2bed-4de9-b169-b2d36277b21c","attributeTranslation":"Participantes enceintes, allaitantes ou qui prévoient une grossesse","language":10,"languageDescription":"French"},{"id":11347129,"uuid":"247ee731-2bed-4de9-b169-b2d36277b21c","attributeTranslation":"Participantes que estén embarazadas, en periodo de lactancia o que tengan previsto quedarse embarazadas","language":7,"languageDescription":"Spanish"},{"id":11347131,"uuid":"247ee731-2bed-4de9-b169-b2d36277b21c","attributeTranslation":"Uczestniczki, które są w ciąży, karmią piersią lub planują zajść w ciążę","language":19,"languageDescription":"Polish"}]},{"id":1569580,"number":6,"principalExclusionCriteria":"Cardiovascular conditions","principalExclusionCriteriaTranslations":[{"id":11347133,"uuid":"ad485928-e29a-452a-8999-dc0ec25015cf","attributeTranslation":"Choroby sercowo-naczyniowe","language":19,"languageDescription":"Polish"},{"id":11347136,"uuid":"ad485928-e29a-452a-8999-dc0ec25015cf","attributeTranslation":"Enfermedades cardiovasculares","language":7,"languageDescription":"Spanish"},{"id":11347135,"uuid":"ad485928-e29a-452a-8999-dc0ec25015cf","attributeTranslation":"Cardiovasculaire aandoening","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347134,"uuid":"ad485928-e29a-452a-8999-dc0ec25015cf","attributeTranslation":"Affections cardiovasculaires","language":10,"languageDescription":"French"}]},{"id":1569581,"number":7,"principalExclusionCriteria":"Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus","principalExclusionCriteriaTranslations":[{"id":11347139,"uuid":"db592cd0-eff2-4d49-97a6-90dc165b309c","attributeTranslation":"Diabetes mellitus type 1 of ongereguleerde diabetes mellitus type 2","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347140,"uuid":"db592cd0-eff2-4d49-97a6-90dc165b309c","attributeTranslation":"Cukrzyca typu 1 lub niekontrolowana cukrzyca typu 2","language":19,"languageDescription":"Polish"},{"id":11347138,"uuid":"db592cd0-eff2-4d49-97a6-90dc165b309c","attributeTranslation":"Diabetes mellitus de tipo 1 o diabetes mellitus de tipo 2 no controlada","language":7,"languageDescription":"Spanish"},{"id":11347137,"uuid":"db592cd0-eff2-4d49-97a6-90dc165b309c","attributeTranslation":"Diabète sucré de type 1 ou diabète sucré de type 2 non contrôlé","language":10,"languageDescription":"French"}]},{"id":1569582,"number":8,"principalExclusionCriteria":"Unstable existing thyroid disease/disorder","principalExclusionCriteriaTranslations":[{"id":11347144,"uuid":"ae003bd2-c155-4ad0-a322-bec009780138","attributeTranslation":"Niestabilna, występująca obecnie choroba tarczycy / zaburzenie czynności tarczycy","language":19,"languageDescription":"Polish"},{"id":11347142,"uuid":"ae003bd2-c155-4ad0-a322-bec009780138","attributeTranslation":"Trastorno/enfermedad tiroidea existente inestable","language":7,"languageDescription":"Spanish"},{"id":11347141,"uuid":"ae003bd2-c155-4ad0-a322-bec009780138","attributeTranslation":"Instabiele bestaande schildklierziekte/-stoornis","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347143,"uuid":"ae003bd2-c155-4ad0-a322-bec009780138","attributeTranslation":"Présence d’une maladie thyroïdienne ou d’un trouble thyroïdien instable","language":10,"languageDescription":"French"}]},{"id":1569583,"number":9,"principalExclusionCriteria":"Positive urine drug screens for illicit drugs or drugs of abuse at Screening will be reviewed with participants to determine the pattern of use","principalExclusionCriteriaTranslations":[{"id":11347148,"uuid":"f55e92d9-7535-4111-8164-26d538502ed3","attributeTranslation":"Positieve urinecontroles op illegale drugs of drugsgebruik tijdens de screening worden samen met de deelnemers bekeken om het gebruikspatroon vast te stellen","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":11347147,"uuid":"f55e92d9-7535-4111-8164-26d538502ed3","attributeTranslation":"Todo resultado positivo en el análisis de orina para la detección de drogas o estupefacientes se examinará con los participantes en la selección con el fin de determinar la pauta de uso","language":7,"languageDescription":"Spanish"},{"id":11347145,"uuid":"f55e92d9-7535-4111-8164-26d538502ed3","attributeTranslation":"Dodatnie wyniki testów przesiewowych z moczu na obecność niedozwolonych substancji lub narkotyków podczas badań przesiewowych zostaną omówione z uczestnikiem w celu ustalenia schematu stosowania","language":19,"languageDescription":"Polish"},{"id":11347146,"uuid":"f55e92d9-7535-4111-8164-26d538502ed3","attributeTranslation":"Des dépistages urinaires positifs de drogues illicites ou de stupéfiants à la sélection seront discutés avec les participants potentiels en vue de déterminer le profil de consommation","language":10,"languageDescription":"French"}]}]},"endPoint":{"primaryEndPoints":[{"id":1072518,"number":1,"endPoint":"COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score at Week 6","isPrimary":true,"endPointTranslations":[{"id":11347067,"uuid":"7a39233f-369c-4361-b155-4b09d2f74c71","attributeTranslation":"COMP360 25 mg frente a COMP360 1 mg para el cambio respecto al valor inicial en la puntuación total de la escala MADRS en la semana 6","language":7,"languageDescription":"Spanish"},{"id":11347068,"uuid":"7a39233f-369c-4361-b155-4b09d2f74c71","attributeTranslation":"Comparaison de COMP360 25 mg par rapport au COMP360 1 mg en matière de variation du score total à l'échelle MADRS entre l'entrée dans l'étude et la Semaine 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6","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[]},"trialDuration":{"estimatedGlobalEndDate":"2027-01-31","estimatedEndDate":"2027-01-31","estimatedRecruitmentStartDate":"2023-11-17"},"sourceOfMonetarySupport":[],"populationOfTrialSubjects":{"ageRanges":[{"id":371533,"ageRangeCategoryCode":"3","ageRangeCategory":"3"},{"id":371534,"ageRangeCategoryCode":"4","ageRangeCategory":"4"}],"ageRangeSecondaryIds":[{"id":371535,"ageRangeCategoryCode":"4","ctAgeRangeCode":"8","ageRangeCategory":"4","ctAgeRange":"8"},{"id":371536,"ageRangeCategoryCode":"4","ctAgeRangeCode":"7","ageRangeCategory":"4","ctAgeRange":"7"}],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":true},"individualParticipantData":{"planToShareIPD":"2"}},"protocolInformation":{"studyDesign":{"periodDetails":[{"id":193937,"businessKey":"1","title":"Part A","description":"Part A will include a nine-week follow-up from initial investigational product (IP) administration.","blindingMethodCode":"2","blindedRoles":[{"id":193938,"code":2,"name":"Investigator"},{"id":193939,"code":1,"name":"Subject"},{"id":193940,"code":4,"name":"Analyst"}],"blindingDetails":"Part A and Part B of the study are double-blind, in which participants, Investigators, MADRS assessors, and the Sponsor are blinded to study intervention. \n\nThe blind will not be broken until all participants have completed the study and database is locked, except in the event of a medical emergency or as required by regulatory authorities (Section 7.5.1).","armDetails":[{"description":"Randomised in a 2:1:1 ratio to COMP360 25 mg, 10 mg or 1 mg respectively.","title":"COMP360 25 mg","id":107855},{"description":"Randomised in a 2:1:1 ratio to COMP360 25 mg, 10 mg or 1 mg respectively.","title":"COMP360 10 mg","id":107856},{"description":"Randomised in a 2:1:1 ratio to COMP360 25 mg, 10 mg or 1 mg respectively.","title":"COMP360 1 mg","id":107857}],"allocationMethod":"1"},{"id":193941,"businessKey":"2","title":"Part B","description":"Part B will include a further 17 weeks follow-up out to 26 weeks from initial IP administration.","blindingMethodCode":"2","blindedRoles":[{"id":193943,"code":1,"name":"Subject"},{"id":193944,"code":2,"name":"Investigator"},{"id":193942,"code":4,"name":"Analyst"}],"blindingDetails":"Part A and Part B of the study are double-blind, in which participants, Investigators, MADRS assessors, and the Sponsor are blinded to study intervention. \n\nThe blind will not be broken until all participants have completed the study and database is locked, except in the event of a medical emergency or as required by regulatory authorities (Section 7.5.1).","armDetails":[{"description":"Randomised in a 2:1:1 ratio to COMP360 25 mg, 10 mg or 1 mg respectively.","title":"COMP360 25 mg","id":107858},{"description":"Randomised in a 2:1:1 ratio to COMP360 25 mg, 10 mg or 1 mg respectively.","title":"COMP360 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mg","id":107863}],"allocationMethod":"3"}]}},"scientificAdviceAndPip":{"scientificAdvices":[{"id":58336,"competentAuthority":{"id":147850,"organisation":{"id":151058,"type":"EEA National Competent authority","typeCode":"16","name":"Federal Institute For Drugs And Medical Devices","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100003923","organisationLocationStatus":"Active"},"address":{"addressId":156047,"oneLine":"Kurt-Georg-Kiesinger-Allee 3, Plittersdorf","addressLine1":"Kurt-Georg-Kiesinger-Allee 3","addressLine2":"Plittersdorf","addressLine3":"","addressLine4":"","city":"Bonn","postcode":"53175","country":2013,"countryName":"Germany"},"isBusinessKeyValidated":true,"businessKey":"LOC-100000024"}},{"id":58337,"competentAuthority":{"id":147857,"organisation":{"id":151067,"type":"EEA National Competent authority","typeCode":"16","name":"Medical Products 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