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

Completed

Conditions studied: Treatment Resistant Depression

In brief

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).

Key facts

Study ID

NCT04519957

Run by

COMPASS Pathways

People needed

66

Starts

2020-07-20

Expected to finish

2022-08-11

Last updated by the study team

2022-09-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• 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

Full record on ClinicalTrials.gov

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