COMP 006
Research type
Research Study
Full title
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
IRAS ID
1006213
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
COMPASS Pathfinder Limited
Eudract number
2022-002339-73
Research summary
A phase IIb, international, multicentre, randomised, double-blind, controlled, dose-finding study (COMP 001) to assess the safety and efficacy of two different single doses of COMP360 (COMPASS Pathfinder Limited’s [COMPASS] proprietary synthetic psilocybin formulation) delivered as monotherapy with psychological support 25 mg and 10 mg versus COMP360 1 mg was conducted in 233 participants with treatment-resistant depression (TRD). For the primary efficacy endpoint, the COMP360 25 mg treatment group versus the COMP360 1 mg treatment group showed a statistically and clinically significant treatment difference of -6.6 points in the change from baseline at Week 3 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (p<0.001). This treatment difference was apparent from the day after the COMP360 administration session up to Week 6, denoting a rapid antidepressant effect after a single administration. Improvements in the COMP360 10 mg treatment group compared to the COMP360 1 mg treatment group were not statistically significant in the change from baseline at Week 3 in MADRS total score. COMP360 was found to be generally well tolerated, and the secondary and exploratory endpoints supported the primary endpoint findings.
In this study, the aim is to assess the efficacy after one and two administrations of COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg for reducing symptom severity in TRD, when administered with psychological support.REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0002
Date of REC Opinion
17 Aug 2023
REC opinion
Further Information Favourable Opinion