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

Treatment Resistant Depression Clinical Trial

Official 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

Clinical Trial Summary

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

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05711940
Study type Interventional
Source COMPASS Pathways
Contact Medical Director, MD
Email COMP006@compasspathways.com
Status Recruiting
Phase Phase 3
Start date February 14, 2023
Completion date May 2025
View Details
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