This is the first part of COMPASS Pathwhays’ Phase III clinical trial program comparing the effects of a single dose of COMP360 (25mg) to a placebo in participants (n=378) with treatment-resistant depression (TRD).
This is the world’s first Phase III clinical trial with psilocybin. This trial is designed to replicate the treatment response seen in COMPASS’S Phase IIb study (n=233).
The primary endpoint in this trial is the change from baseline in MADRS total score at Week 6.
In March 2023, during an investor call, the number of participants was reduced from 378 to 255. This will lead to an earlier completion date but less robust data (still, 255 will make this one of the largest psychedelic trials).
Original title: A Single Dose of COMP360 for Treatment-Resistant Depression
Trial Details
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, 378 participants will be randomised in a 2:1 ratio to receive COMP360 25 mg or placebo. The study will last up to 16 weeks, including a three- to ten-week Screening Period and a six-week follow-up from investigational product (IP) administration. In this study, the aim is to assess the efficacy of COMP360 25 mg versus placebo for reducing symptom severity in TRD, when administered with psychological support.NCT Number NCT05624268
Sponsors & Collaborators
COMPASS PathwaysCOMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.
Post Linked
The Ethical Compass of Minding to Psychotherapy: How Much Support is Necessary?A battle of Compass Pathways (Guy Goodwin) vs the MIND Foundation (Max Wolff). The need for psychotherapy or just psychological support.