Clinical TrialTreatment-Resistant Depression (TRD)Completed

Long Term Follow Up Study to 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).

Target Enrollment
66 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

This prospective, observational long-term follow-up (COMP 004) follows participants from COMP 001 and COMP 003 to assess efficacy and safety of three psilocybin dosing regimens (1 mg, 10 mg, 25 mg) over a 52-week period using remote and digital assessments.

Participants previously treated in COMP 001 are followed for approximately 40 weeks and those from COMP 003 for approximately 49 weeks, yielding up to 52 weeks of follow-up from psilocybin dosing; outcomes include new antidepressant use, hospitalisations for depression, suicidality and MADRS scores.

The study uses remote/digital data collection and includes multiple international sites; planned target was 150 with 66 participants recorded as actual enrollment in the registry fragment.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • 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

  • Exclusion Criteria:
  • Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject e.g. participation could compromise the wellbeing of the participant or prevent, limit, or confound the protocol-specified assessments

Study Details

Locations

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

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