CompletedN/AOther
Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)
Sponsored by COMPASS Pathways
NCT ID
NCT04519957
Target Enrollment
66 participants
Start Date
2020-07-20
Est. Completion
2022-08-11
About This Study
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).
Conditions Studied
Eligibility
Age:18 Years - 55 Years
View full eligibility criteria
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
Study Locations (8)
Kadima Neuropsychiatry Institute
La Jolla, California, United States
Altman Clinical and Translational Research Institute, University of California
San Diego, California, United States
Mood and Anxiety Disorders Program Emory University School of Medicine
Atlanta, Georgia, United States
UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
Houston, Texas, United States
National Institute of Mental Health Czech Republic
Klecany, Czechia
Sheaf House, Tallaght Hospital
Dublin, Ireland
Groningen University Medical Centre
Groningen, Netherlands
Kings College London, Institute of Psychiatry, Psychology and Neurology
London, United Kingdom