COMP004
Research type
Research Study
Full title
A multicentre study to assess safety and efficacy of COMP360 in patients with treatment-resistant depression following completion of COMP 001 and COMP 003 trials (P-TRD LTFU)
IRAS ID
297956
Contact name
Allan Young
Contact email
Sponsor organisation
COMPASS Pathfinder, Ltd
Eudract number
2020-001348-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not Applicable, Not Applicable
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
A recent open-label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid, significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support.
The aim of this study is to follow up participants from COMP 001 and COMP 003 in a long-term follow up study, with both remote and digital assessments, to explore the long term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP 001 and 25 mg psilocybin administered as an adjunct to an selective serotonin reuptake inhibitors (SSRI) in COMP 003.
Approximately 150 participants will be enrolled into this study, at up to 23 different study centres across Europe and North America.
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0342
Date of REC Opinion
24 Jun 2021
REC opinion
Further Information Favourable Opinion