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).
Details
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.