Informations générales (source: ClinicalTrials.gov)
A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression
Interventional
Phase 3
COMPASS Pathways (Voir sur ClinicalTrials)
février 2023
mai 2025
03 décembre 2024
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with
treatment-resistant depression (TRD)
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GHU PARIS PSY ET NEUROSCIENCES | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau - 30000 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique - 75014 - Paris - France | Lucie Berkovitch | Contact (sur clinicalTrials) | |||
| Universite Paris VI Pierre et Marie Curie - Hopital de La Salpetriere - Centre Emotion - USR 3246 (CNRS UMR 7593) - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Aged ≥18 years at Screening
2. Major depression without psychotic features (single or recurrent episode as informed
by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
3. If the current major depressive episode is the participant's first lifetime episode
of depression, the length of the current episode must be ≥3 months and ≤2 years at
Screening
4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity
of depression
5. TRD, defined as failure to respond to an adequate dose and duration of two, three,
or four different pharmacological treatments for the current episode as determined
through the Massachusetts General Hospital Antidepressant Treatment Response
Questionnaire (MGH-ATRQ) and using the supplementary advice on additional
antidepressants not included in MGH-ATRQ
6. At Screening, agreement to discontinue all prohibited medications
Key
1. Aged ≥18 years at Screening
2. Major depression without psychotic features (single or recurrent episode as informed
by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
3. If the current major depressive episode is the participant's first lifetime episode
of depression, the length of the current episode must be ≥3 months and ≤2 years at
Screening
4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity
of depression
5. TRD, defined as failure to respond to an adequate dose and duration of two, three,
or four different pharmacological treatments for the current episode as determined
through the Massachusetts General Hospital Antidepressant Treatment Response
Questionnaire (MGH-ATRQ) and using the supplementary advice on additional
antidepressants not included in MGH-ATRQ
6. At Screening, agreement to discontinue all prohibited medications
Key
1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia,
schizophreniform disorder, schizoaffective disorder, brief psychotic disorder
(unless substance induced or due to a medical condition), antisocial personality
disorder as assessed by a structured clinical interview (MINI 7.0.2)
2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality
disorder, or any ongoing serious psychiatric comorbidity based on medical history
and clinical judgement
3. Borderline personality disorder as demonstrated by medical history or the Mini
International Neuropsychiatric Interview Plus (MINI plus) - borderline personality
disorder module
4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia
nervosa as assessed by medical history and a structured clinical interview (MINI
7.0.2)
5. Psychiatric inpatient within the past 12 months prior to Screening
6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation
during the current depressive episode
7. Transcranial magnetic stimulation within the past six months prior to Screening
8. Current enrolment in a psychological therapy programme that will not remain stable
for the duration of the study. Psychological therapies cannot have been initiated
within 30 days prior to Screening
9. Exposure to COMP360 psilocybin therapy prior to Screening