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

N/ACompletedNCT04519957

COMPASS Pathways66 enrolled

Overview

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).

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

Conditions

Treatment Resistant Depression

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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)

Time frame: up to 52 weeks

Secondary Outcomes

Response, sustained response, remission and change in depression severity

Montgomery Asberg Depression Rating Scale (MADRS)

Time frame: 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

Time frame: 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

Time frame: Up to 52 weeks

Safety of Psilocybin

Incidence and severity of Adverse Events (AEs) and Seroius Adverse Events (SAEs)

Time frame: Up to 52 weeks

Data from ClinicalTrials.gov

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