Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)

The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001).

Topic Treatment-Resistant Depression
Compound Psilocybin
Country Czech Republic United States of America Ireland United Kingdom Netherlands
Visit trial
Status Recruiting
Results Published
Start date 20 July 2020
End date 01 September 2022
Chance of happening 100%
Phase Not Applicable
Design Open
Type Observational
Participants 150
Sex All
Age 18- 55
Therapy Yes

Trial Details

In this present study (COMP 004), the aim 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 SSRI in COMP 003. Patients previously treated in COMP001 will be followed for approximately 40 weeks and patients previosuly treated in COMP003 will be followed for approximately 49 weeks giving a total follow up period of 52 weeks from psilocybin dosing.

NCT Number NCT04519957

Sponsors & Collaborators

COMPASS Pathways
COMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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