Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
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
Sponsor: COMPASS Pathways
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.
Time frame: Week 6
Secondary Endpoints
COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score.
COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
Eligibility 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: 1. Prior or ongoing bipolar disor…
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