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Psilocybin-assisted CBT for Depression

Not yet recruitingRegisteredCTG

Phase I/II study (n=62 estimated) testing two fixed psilocybin doses (10 mg then 25 mg, one month apart) combined with either 12-session PA-CBT or 6-session minimal supportive therapy in adults with major depressive disorder to assess feasibility, acceptability and preliminary efficacy.

Details

This study includes a Phase I open trial (n≈12) of psilocybin-assisted CBT (PA-CBT) followed by a Phase II randomized, parallel-group trial (n≈50) comparing PA-CBT (12 sessions) with a minimal supportive therapy condition (6 sessions).

All participants receive two oral psilocybin sessions (10 mg then 25 mg, one month apart). Outcomes include feasibility, acceptability, adherence, and clinical measures of depressive symptoms (HAM-D) and safety assessments.

Topics:Major Depressive Disorder (MDD)

Registry

Registry linkNCT05227612