Treatment Resistant Depression
Conditions
Brief summary
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)
Detailed description
This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 255 participants will be randomised in a 2:1 ratio to receive COMP360 25 mg or placebo. The study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week Screening Period. Part A will include a six-week follow-up from initial investigational product (IP) administration. In this study, the primary aim is to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD, when administered with psychological support. This will be assessed in a 6-week, single-dose, double-blind, placebo-controlled part of the study (Part A). Durability of efficacy and long-term safety, and the efficacy and safety of re-treatment will be assessed in a 20-week single-dose, double-blind re-treatment part (Part B), and a 26-week open-label treatment part (Part C).
Interventions
DRUGPsilocybin
COMP360 Psilocybin administered under supportive conditions
Sponsors
COMPASS Pathways
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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
Exclusion criteria
Psychiatric
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COMP360 25 mg versus placebo for the change from baseline in MADRS total score | Week 6 | Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COMP360 25 mg versus placebo for the change from baseline in SDS total score | Week 6 | Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life. |
Countries
United States
Outcome results
None listed