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Psilocybin Therapy for Depression in Bipolar II Disorder (BAP)

Not yet recruitingRegisteredCTG

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.

Details

Open-label, single-arm pilot enrolling 14 adults with Bipolar II disorder and current depression to assess safety, tolerability, and feasibility of psilocybin therapy with preparatory and integration sessions.

Participants receive one or two supervised oral psilocybin sessions (10–25 mg) ~3 weeks apart; primary outcomes are safety and feasibility and efficacy is explored via change in MADRS three weeks after final administration, with additional measures of sleep, quality of life, and therapeutic engagement.

Topics:Bipolar Disorder

Registry

Registry linkNCT05065294