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 (COMP36).
Compound Psilocybin
Country United Kingdom
Visit trial
Status
Recruiting
Results Published
No
Start date
01 February 2023
End date
01 May 2025
Chance of happening
89%
Phase
Phase III
Design
Blinded
Type
Interventional
Generation
Second
Participants
568
Sex
All
Age
18- 65
Therapy
No
Trial Details
This is a phase III, international, multi-centre, randomised, parallel group, fixed repeat dose, double-blind, controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 568 participants are to be randomised in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg. The study will last up to 16 weeks including a three- to ten-week Screening Period and six-week follow-up from investigational product (IP) administration. In this study, the aim is to assess the efficacy of COMP360, administered with psychological support in adult participants with TRD, in improving symptoms of depression.NCT 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.