U.S., April 25 -- ClinicalTrials.gov registry received information related to the study (NCT06943573) titled 'Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder' on April 01.
Brief Summary: This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e. que...