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

Multicentre Study To Assess Safety And Efficacy Of Psilocybin In Patients With Treatment-Resistant Depression Following Completion Of 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).

Study Overview

• Status: Completed
• Conditions: Treatment Resistant Depression

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Czechia
  • Klecany, Czechia
    • National Institute of Mental Health Czech Republic
• Ireland
  • Dublin, Ireland
    • Sheaf House, Tallaght Hospital
• Netherlands
  • Groningen, Netherlands
    • Groningen University Medical Centre
• United Kingdom
  • London, United Kingdom
    • Kings College London, Institute of Psychiatry, Psychology and Neurology
• United States
  • California
    • La Jolla, California, United States, 92037
      • Kadima Neuropsychiatry Institute
    • San Diego, California, United States, 92093
      • Altman Clinical and Translational Research Institute, University of California
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Mood and Anxiety Disorders Program Emory University School of Medicine
  • Texas
    • Houston, Texas, United States, 77054
      • UT Center of Excellence on Mood Disorders, University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

TRD patients who completed COMP001 or COMP003

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response, sustained response, remission and change in depression severity	Montgomery Asberg Depression Rating Scale (MADRS)	Up to 52 weeks
Psychosocial functioning and to predict durability of response to antidepressant treatment	Work and Social Adjustment Scale (WSAS) score change from Baseline of the prior study	up to 52 weeks
Functional impairment in work/school, social life, and family life.	Sheehan Disability Scale (SDS) score change from Baseline of the prior study	Up to 52 weeks
Safety of Psilocybin	Incidence and severity of Adverse Events (AEs) and Seroius Adverse Events (SAEs)	Up to 52 weeks

Collaborators and Investigators

• Sponsor: COMPASS Pathways

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: COMP004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No