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

NCT04519957 · COMPASS Pathways

Closed to entry
Status
Not accepting participants
Not applicable
Phase
66
Target enrolment
8
Study sites
3 US states

What it is testing

Summary

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Long-term efficacy of psilocybin

    Measured over up to 52 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 55 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: Signed ICF Each participant having completed the final study visit of either COMP 001 or COMP 003 Ability to complete all protocol required assessment tools (including having access to the internet in order to complete the digital assessments) without any assistance or alteration to the copyrighted assessments, and to comply with all study visits Exclusion Criteria: Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject eg participation could compromise the wellbeing of the participant or prevent, limit, or confound the protocol-specified assessments

Where

8 study sites

FacilityCityRegionCountry
Kadima Neuropsychiatry InstituteLa JollaCaliforniaUnited States
Altman Clinical and Translational Research Institute, University of CaliforniaSan DiegoCaliforniaUnited States
Mood and Anxiety Disorders Program Emory University School of MedicineAtlantaGeorgiaUnited States
UT Center of Excellence on Mood Disorders, University of Texas Health Science CenterHoustonTexasUnited States
National Institute of Mental Health Czech RepublicKlecany—Czechia
Sheaf House, Tallaght HospitalDublin—Ireland
Groningen University Medical CentreGroningen—Netherlands
Kings College London, Institute of Psychiatry, Psychology and NeurologyLondon—United Kingdom

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04519957 on ClinicalTrials.gov →

Last updated in the registry 2022-09-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 9 trials from COMPASS Pathways →