A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Major Depressive Disorder With One Prior Treatment Failure

This Phase II interventional trial (n=102) explores the safety, tolerability, pharmacokinetics, and efficacy of COMP360, a psilocybin-based drug, in adults with Major Depressive Disorder (MDD) who have experienced one prior treatment failure of an antidepressant. Conducted by COMPASS Pathways, this study commenced on January 30, 2023, and is estimated to conclude in June 2024.

The trial involves a multi-centre, randomised, double-blind, controlled design, enrolling participants aged 18 years and older with MDD. A total of 102 participants will be randomised in a 2:1 ratio to receive either COMP360 25 mg or COMP360 1 mg. The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of COMP360 administered with psychological support. The primary outcome measures include the proportion of patients with adverse events up to Week 6, while secondary outcome measures involve assessing plasma concentrations of psilocybin, psilocin, 4-hydroxyindoleacetic acid (4-HIAA), and psilocin-O-glucuronide post-COMP360 administration on Day 1. Additionally, the change from baseline in MADRS total score at Week 3 and Week 6 for COMP360 25 mg versus COMP360 1 mg will be evaluated using the Montgomery-Åsberg Depression Rating Scale (MADRS).

The study, led by Medical Director, MD, is recruiting participants in Rockville, Maryland, United States, at Sunstone Therapies. The eligibility criteria include being aged 18 years and older, having MDD without psychotic features, and experiencing failure to respond to one pharmacological treatment for the current depressive episode. The trial’s estimated completion date is June 2024.

Topic Treatment-Resistant Depression Depression
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 30 January 2023
End date 30 June 2024
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 102
Sex All
Age 18- 99
Therapy Yes

Trial Details

Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with Major Depressive Disorder with one prior treatment failure.

Trial Number NCT05733546

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.

Data attribution

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