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
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
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
La Jolla, California 92037-1337, United States
Saint Charles, Missouri 63304, United States
Cincinnati, Ohio 45219, United States
Plano, Texas 75251, United States
Nîmes, 30000, France
Paris, 75013, France
Paris, 75014, France
Frankfurt, 60528, Germany
Leiden, 2300, Netherlands
Chertsey, KT16 9AU, United Kingdom
Doncaster, DN4 8QN, United Kingdom
Fulbourn, CB21 5EF, United Kingdom
Newcastle, NE4 5PL, United Kingdom
Nottingham, NG7 2TU, United Kingdom