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

Completed

• Conditions: Treatment Resistant Depression

• Registration Number: NCT04519957
• Lead Sponsor: COMPASS Pathways

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).

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 Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Primary Completion: 2022-08-11
• Study Completion: 2022-08-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term efficacy of psilocybin	up to 52 weeks	Use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

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

Trial Locations

Locations (8)

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

Groningen University Medical Centre; 🇳🇱 Groningen, Netherlands

Kings College London, Institute of Psychiatry, Psychology and Neurology; 🇬🇧 London, United Kingdom

Kadima Neuropsychiatry Institute; 🇺🇸 La Jolla, California, United States

Altman Clinical and Translational Research Institute, University of California; 🇺🇸 San Diego, California, United States

National Institute of Mental Health Czech Republic; 🇨🇿 Klecany, Czechia

Sheaf House, Tallaght Hospital; 🇮🇪 Dublin, Ireland