NCT05711940

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 572 (actual)
• Sponsor: COMPASS Pathways · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Detailed description

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 comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week screening period. Part A will include a nine-week follow-up from initial investigational product (IP) administration. Part B will include a further 17 weeks follow-up out to 26 weeks from initial IP administration. Part C will include a further 26 weeks follow-up out to 52 weeks from initial 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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Psilocybin	COMP360 Psilocybin administered under supportive conditions

Timeline

• Start date: 2023-02-14
• Primary completion: 2026-02-01
• Completion: 2026-12-01
• First posted: 2023-02-03
• Last updated: 2026-01-12

Locations

116 sites across 12 countries: United States, Canada, Czechia, Denmark, France, Germany, Ireland, Netherlands, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study