Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (COMP 006)

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‘

Topic Treatment-Resistant Depression
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 Pathways
COMPASS 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 Scale
A 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.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.