This is the second part of COMPASS Pathways’ Phase III clinical trial program exploring the effects of fixed repeated doses of COMP360 (25mg, 10mg & 1mg) in participants (n=568) with treatment-resistant depression (TRD).
This trial is designed to investigate if a second dose can increase the number of responders and/or improve the response seen in the COMPASS’S Phase IIb study and explore the potential for a meaningful treatment response from repeat administration of COMP360 10mg. The primary endpoint in this trial is the change from baseline in MADRS total score at Week 6.
This trial forms part of the world’s first Phase III clinical trial with psilocybin (COMP360).
This trial is also registered in the UK as ‘Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD‘
Trial Details
Trial Number
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.