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

NCT04519957 | Completed

• 1 other identifier: COMP004
• Study Type: observational
• Target: 66
• Locations: 5 countries
• Sites: 8

Brief 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).

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Long-term efficacy of psilocybin

  Use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS)

  up to 52 weeks

Secondary Outcomes (4)

• Response, sustained response, remission and change in depression severity

  Up to 52 weeks

• Psychosocial functioning and to predict durability of response to antidepressant treatment

  up to 52 weeks

• Functional impairment in work/school, social life, and family life.

  Up to 52 weeks

• Safety of Psilocybin

  Up to 52 weeks

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

TRD patients who completed COMP001 or COMP003

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

Sponsors & Collaborators

• COMPASS Pathways: lead

Study Sites (8)

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

Altman Clinical and Translational Research Institute, University of California

San Diego, California, 92093, United States

Location

Mood and Anxiety Disorders Program Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

UT Center of Excellence on Mood Disorders, University of Texas Health Science Center

Houston, Texas, 77054, United States

Location

National Institute of Mental Health Czech Republic

Klecany, Czechia

Location

Sheaf House, Tallaght Hospital

Dublin, Ireland

Location

Groningen University Medical Centre

Groningen, Netherlands

Location

Kings College London, Institute of Psychiatry, Psychology and Neurology

London, United Kingdom

Location

Related Publications (1)

• Goodwin GM, Nowakowska A, Atli M, Dunlop BW, Feifel D, Hellerstein DJ, Marwood L, Shabir Z, Mistry S, Stansfield SC, Teoh E, Tsai J, Young MB, Malievskaia E. Results From a Long-Term Observational Follow-Up Study of a Single Dose of Psilocybin for a Treatment-Resistant Episode of Major Depressive Disorder. J Clin Psychiatry. 2025 Mar 3;86(1):24m15449. doi: 10.4088/JCP.24m15449.

  PMID: 40047545 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 20, 2020
• Study Start: July 20, 2020
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

US (4); CZ (1); NL (1); GB (1); IE (1)