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treatment-resistant depression.","fullTitleTranslations":[{"id":4097053,"uuid":"68528d68-9e0c-4475-8d1d-95c2dd02954d","attributeTranslation":"Randomizowane badanie fazy IIb prowadzone metodą podwójnie ślepej próby z grupą kontrolną otrzymującą placebo, z badaniem kontynuacyjnym prowadzonym metodą  otwartej próby, mające na celu określenie bezpieczeństwa stosowania i skuteczności produktu  GH001 u pacjentów z depresją lekooporną","language":19,"languageDescription":"Polish"},{"id":4097054,"uuid":"68528d68-9e0c-4475-8d1d-95c2dd02954d","attributeTranslation":"Ensayo aleatorizado, doble ciego, controlado con placebo, de fase 2b, con una extensión \nabierta para determinar la seguridad y eficacia de GH001 en pacientes con depresión resistente al \ntratamiento.","language":7,"languageDescription":"Spanish"}],"publicTitle":"A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression.","publicTitleTranslations":[{"id":4097062,"uuid":"6d0117fb-c8d6-4440-a499-ef90535f0494","attributeTranslation":"Randomizowane badanie fazy IIb prowadzone metodą podwójnie ślepej próby z grupą kontrolną otrzymującą placebo, z badaniem kontynuacyjnym prowadzonym metodą  otwartej próby, mające na celu określenie bezpieczeństwa stosowania i skuteczności produktu  GH001 u pacjentów z depresją lekooporną","language":19,"languageDescription":"Polish"},{"id":4097061,"uuid":"6d0117fb-c8d6-4440-a499-ef90535f0494","attributeTranslation":"Ensayo aleatorizado, doble ciego, controlado con placebo, de fase 2b, con una extensión  abierta para determinar la seguridad y eficacia de GH001 en pacientes con depresión resistente al tratamiento.","language":7,"languageDescription":"Spanish"}],"shortTitle":"GH001-TRD-201","secondaryIdentifyingNumbers":{"nctNumber":{"id":282282,"number":"NCT05800860"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"Phase IIb trial","trialCategoryId":50873},"medicalCondition":{"partIMedicalConditions":[{"id":58627,"medicalCondition":"Treatment-resistant depression (TRD)","medicalConditionTranslations":[{"id":4097034,"uuid":"d696eb7b-3be3-47bd-a7d0-4d16bb24af3c","attributeTranslation":"Depresión resistente al tratamiento","language":7,"languageDescription":"Spanish"},{"id":4097033,"uuid":"d696eb7b-3be3-47bd-a7d0-4d16bb24af3c","attributeTranslation":"Depresja lekooporna","language":19,"languageDescription":"Polish"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000024349,"version":"21.1","level":"PT","termName":"Major 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resistente al tratamiento (DRT) al final de los 7 días de la parte 1 con doble enmascaramiento (DE) del estudio.","language":7,"languageDescription":"Spanish"},{"id":4097059,"uuid":"0b235c48-2e5d-4171-840f-6036669e409b","attributeTranslation":"Określenie wpływu jednodniowego spersonalizowanego schematu dawkowania produktu GH001 w porównaniu z placebo na poprawę objawów podmiotowych depresji na podstawie oceny z użyciem skali MADRS u pacjentów z depresją lekooporną na koniec 7-dniowej części 1 badania prowadzonej metodą podwójnie ślepej próby.","language":19,"languageDescription":"Polish"}],"secondaryObjectives":[{"id":189057,"number":1,"secondaryObjective":"To determine the effect of a single day IDR of GH001 compared with  placebo on depressive symptoms as assessed by MADRS, global disease  severity as assessed by CGI-S, anxiety as assessed by HAM-A, and  quality of life as assessed by Q-LES-Q-SF in patients with TRD at the end  of the 7-day DB Part 1.","secondaryObjectiveTranslations":[{"id":4097063,"uuid":"3a6dac8c-9970-49fb-bd7f-f4627d0f3ddf","attributeTranslation":"Określenie wpływu jednodniowego spersonalizowanego schematu dawkowania produktu GH001 w porównaniu z placebo na objawy podmiotowe depresji oceniane w skali MADRS, ogólne nasilenie choroby oceniane z użyciem CGI-S, niepokój oceniany za pomocą narzędzia HAM-A i jakość życia ocenianą z użyciem kwestionariusza Q-LES-Q-SF u pacjentów z depresją lekooporną na koniec 7-dniowej części 1 prowadzonej metodą podwójnie ślepej próby.","language":19,"languageDescription":"Polish"},{"id":4097064,"uuid":"3a6dac8c-9970-49fb-bd7f-f4627d0f3ddf","attributeTranslation":"•\tDeterminar el efecto de una PAI de un solo día de GH001 en comparación con un placebo en los síntomas depresivos según lo evaluado por la escala MADRS, la gravedad global de la enfermedad según lo evaluado por la escala de impresión clínica global de la gravedad (CGI-S, por su sigla en inglés), la ansiedad según lo evaluado por la escala de ansiedad de Hamilton (HAM-A, por su sigla en inglés) y la calidad de vida según lo evaluado por el cuestionario sobre calidad de vida en términos de disfrute y satisfacción (Q LES-Q-SF, por su sigla en inglés) en pacientes con DRT al final de los 7 días de la parte 1 con DE del estudio.","language":7,"languageDescription":"Spanish"}]},{"id":189058,"number":2,"secondaryObjective":"To determine the effect of GH001 IDR as needed on depressive  symptoms as assessed by MADRS, global disease severity as assessed by CGI-S, anxiety as assessed by the HAM-A, and quality of life as assessed  by Q-LES-Q-SF in patients with TRD during the 6-month open-label  extension (OLE) Part 2.","secondaryObjectiveTranslations":[{"id":4097066,"uuid":"7dcb7272-ec78-4e46-98bd-28c1eb2693d9","attributeTranslation":"Determinar el efecto de una PAI a discreción de GH001 en los síntomas depresivos según lo evaluado por la escala MADRS, la gravedad global de la enfermedad según lo evaluado por la escala CGI S, la ansiedad según lo evaluado por la escala HAM A y la calidad de vida según lo evaluado por el cuestionario Q LES Q SF en pacientes con DRT durante los 6 meses de la parte 2 de extensión sin enmascaramiento (ESE) del estudio.","language":7,"languageDescription":"Spanish"},{"id":4097065,"uuid":"7dcb7272-ec78-4e46-98bd-28c1eb2693d9","attributeTranslation":"•\tOkreślenie wpływu spersonalizowanego schematu dawkowania produktu GH001 podawanego doraźnie na objawy podmiotowe depresji oceniane w skali MADRS, ogólne nasilenie choroby oceniane z użyciem CGI-S, niepokój oceniany za pomocą narzędzia HAM-A i jakość życia ocenianą z użyciem kwestionariusza Q-LES-Q-SF u pacjentów z depresją lekooporną w 6-miesięcznej części 2 stanowiącej badanie kontynuacyjne prowadzone metodą otwartej próby.","language":19,"languageDescription":"Polish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":368168,"number":1,"principalInclusionCriteria":"Is in the age range between 18 and 64 years (inclusive) at the time of  informed consent.","principalInclusionCriteriaTranslations":[{"id":4097055,"uuid":"aeb66a69-0bfb-4d33-a11b-2cf2393e3592","attributeTranslation":"Wiek od 18 do 64 lat (włącznie) w czasie świadomej zgody.","language":19,"languageDescription":"Polish"},{"id":4097056,"uuid":"aeb66a69-0bfb-4d33-a11b-2cf2393e3592","attributeTranslation":"El paciente está en el rango de edad entre 18 y 64 años (inclusive) en el momento del consentimiento informado.","language":7,"languageDescription":"Spanish"}]},{"id":368169,"number":2,"principalInclusionCriteria":"Meets the trial criteria for TRD as assessed by a study psychiatrist: a.Meets the Diagnostic and Statistical Manual of Mental Disorders 5  (DSM-5) criteria for single-episode MDD or recurrent MDD, without  psychotic features confirmed by the Mini-International Neuropsychiatric  Interview (MINI) 7.0.2 with current episode duration of ≤2 years. b.The current MDE must be deemed \"valid\" based upon the  Massachusetts General Hospital State versus trait Assessability Face and Ecological validity Rule of 3Ps (MGH SAFER) criteria interview. c.Had nonresponse (≤25% improvement) to ≥2 and ≤5 oral  antidepressant treatments started during the current episode of  depression.","principalInclusionCriteriaTranslations":[{"id":4097058,"uuid":"a69a3aee-11e8-4fd3-a132-7e45a07c27a5","attributeTranslation":"Reunir los criterios de diagnóstico de DRT establecidos para el ensayo según lo evaluado por un psiquiatra del estudio:\na.Reunir los criterios de la versión 5 del Manual Diagnóstico y Estadístico de los Trastornos Mentales (DSM-5, por su sigla en inglés) para un diagnóstico de episodio único de trastorno depresivo mayor (TDM) o de TDM recurrente sin rasgos psicóticos según lo confirmado por la version 7.0.2 de la entrevista neuropsiquiátrica internacional breve (MINI, por su sigla en inglés), con una duración del episodio actual ≤2 años.\nb.El diagnóstico de episodio depresivo mayor (EDM) debe considerarse «válido» según los criterios de la entrevista SAFER (State versus trait Assessability Face and Ecological validity Rule of 3Ps) del Massachusetts General Hospital (MGH).\nc.Ausencia de respuesta (mejoría ≤25 %) a entre ≥2 y ≤5 tratamientos antidepresivos empezados por vía oral durante el episodio depresivo actual.","language":7,"languageDescription":"Spanish"},{"id":4097057,"uuid":"a69a3aee-11e8-4fd3-a132-7e45a07c27a5","attributeTranslation":"Spełnianie kryteriów badania dotyczących depresji lekoopornej, ocenionych przez psychiatrę prowadzącego badanie:\na.\tKryteria pojedynczego epizodu dużego zaburzenia depresyjnego (MDD) lub nawracającego MDD bez cech psychotycznych zgodnie z „Kryteriami diagnostycznymi zaburzeń psychicznych”, wydanie 5 (DSM-5), potwierdzone w kwestionariuszu MINI, przy czym obecny epizod trwa od ≤2 lat.\nb.\tAktualny epizod dużego zaburzenia depresyjnego musi być uznany za ważny na podstawie kryteriów MGH-SAFER.\nc.\tBrak odpowiedzi (poprawa o ≤25%) na ≥2 do ≤5 doustnych leków przeciwdepresyjnych rozpoczęte podczas obecnego epizodu depresji","language":19,"languageDescription":"Polish"}]}],"principalExclusionCriteria":[{"id":634983,"number":1,"principalExclusionCriteria":"Has, based on history, psychiatric assessment, and evaluation of the  MINI during the screening period, a first MDD episode after age 60, a  current or prior diagnosis of a psychotic disorder, MDD, or other mood  disorder with psychotic features, bipolar disorder, obsessive compulsive  disorder, posttraumatic stress disorder, autism spectrum disorder,  borderline personality disorder, schizophrenia, delusional disorder,  paranoid personality disorder, schizoaffective disorder, clinically  significant intellectual disability, antisocial personality disorder,  schizotypal personality disorder, or any other psychiatric comorbidity  that renders the patient unsuitable for the trial according to a study  psychiatrist.","principalExclusionCriteriaTranslations":[{"id":4097038,"uuid":"61f67662-226a-4df7-a2b6-4f8840b3a516","attributeTranslation":"Según los antecedentes médicos, la exploración psiquiátrica y la evaluación de la entrevista MINI efectuados durante el período de selección, haber padecido el primer episodio de TDM después de los 60 años o presentar un diagnóstico actual o haber presentado uno previo de un trastorno psicótico, TDM u otro trastorno anímico con asgos\npsicóticos, trastorno bipolar, trastorno obsesivo compulsivo, trastorno de estrés postraumático, trastorno del espectro autista, trastorno límite de la personalidad, esquizofrenia, trastorno delirante, trastorno paranoide de la personalidad, trastorno esquizoafectivo, discapacidad intelectual de trascendencia clínica, trastorno de personalidad antisocial, trastorno de personalidad esquizotípica o cualquier otra comorbilidad psiquiátrica que cause que el paciente no se considere apto para participar en el ensayo según lo determinado por el psiquiatra del estudio.","language":7,"languageDescription":"Spanish"},{"id":4097037,"uuid":"61f67662-226a-4df7-a2b6-4f8840b3a516","attributeTranslation":"Pacjent, u którego na podstawie wywiadu, oceny psychiatrycznej i kwestionariusza MINI wypełnionego w okresie przesiewowym stwierdza się pierwszy epizod MDD po 60 roku życia, obecnie lub wcześniej rozpoznane zaburzenie psychotyczne, MDD lub inne zaburzenie nastroju z cechami psychotycznymi, chorobę afektywną dwubiegunową, zaburzenie obsesyjno-kompulsywne, zespół stresu pourazowego, zaburzenie ze spektrum autyzmu, zaburzenie osobowości typu borderline, schizofrenię, zaburzenie urojeniowe, zaburzenie osobowości typu paranoidalnego, zaburzenie schizoafektywne, klinicznie istotną niepełnosprawność intelektualną, antyspołeczne zaburzenie osobowości, schizotypowe zaburzenie osobowości lub inne współistniejące schorzenia psychiatryczne, które sprawiają, że pacjent nie kwalifikuje się do badania według psychiatry prowadzącego badanie.","language":19,"languageDescription":"Polish"}]},{"id":634984,"number":2,"principalExclusionCriteria":"Has significant suicide risk as defined by (a) suicidal ideation as  endorsed on items 4 or 5 on the C-SSRS within the past year, during the  screening period, or at Baseline; or (b) suicidal behaviors within the past year; or (c) clinical assessment of significant suicidal risk during clinical  interview; or (d) non-suicidal self-injury within the past year.","principalExclusionCriteriaTranslations":[{"id":4097039,"uuid":"bdc79957-503c-4f78-8b1a-74786316f103","attributeTranslation":"Pacjent z istotnym ryzykiem popełnienia samobójstwa określanym jako (a) myśli samobójcze opisane w pytaniach 4 lub 5 kwestionariusza C-SSRS w ostatnim roku, w okresie przesiewowym lub w punkcie wyjściowym; (b) zachowania samobójcze w ostatnim roku; (c) ocena kliniczna podczas wywiadu klinicznego wskazująca na istotne ryzyko popełnienia samobójstwa; (d) przypadek samookaleczenia bez zamiaru samobójczego w ostatnim roku.","language":19,"languageDescription":"Polish"},{"id":4097040,"uuid":"bdc79957-503c-4f78-8b1a-74786316f103","attributeTranslation":"Presentar un riesgo de suicidio significativo, definido por (a) ideación suicida según los ítems 4 o 5 de la escala Columbia para calificar la gravedad de la ideación suicida (C‑SSRS, por su sigla en inglés) en el último año, durante el período de selección o al inicio del estudio; (b)conductas suicidas en el último año;(c) riesgo suicida significativo\nsegún una evaluación clínica realizada durante la entrevista clínica; o (d) autolesiones sin intención suicida en el último año.","language":7,"languageDescription":"Spanish"}]},{"id":634985,"number":3,"principalExclusionCriteria":"Has 1 or more first degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder, or other mood disorder (including  MDD) with psychotic features.","principalExclusionCriteriaTranslations":[{"id":4097042,"uuid":"7cb44874-fee1-4968-abf5-5e3e75b9a4b0","attributeTranslation":"Tener uno o más familiares de primer grado con un diagnóstico actual o previo de trastorno bipolar, trastorno psicótico u otro trastorno del estado de ánimo (incluido TDM) con rasgos psicóticos.","language":7,"languageDescription":"Spanish"},{"id":4097041,"uuid":"7cb44874-fee1-4968-abf5-5e3e75b9a4b0","attributeTranslation":"Pacjent z co najmniej jednym krewnym pierwszego stopnia z obecnie lub uprzednio rozpoznaną chorobą afektywną dwubiegunową, zaburzeniem psychotycznym lub innym zaburzeniem nastroju (w tym MDD) z cechami psychotycznymi.","language":19,"languageDescription":"Polish"}]},{"id":634986,"number":4,"principalExclusionCriteria":"Undergoing systematic psychotherapy (including cognitive behavioral  therapy [CBT]) that is planned to be modified or planning to initiate  psychotherapy during the trial. 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