Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression

This open-label, interventional trial (n=10) will assess the safety and acceptability of up to two sequential doses of 25 mg psilocybin, administered with therapeutic support, in individuals with Bipolar II disorder (BD-II) depression experiencing suicidal ideation.

Conducted by the University of Texas Health Science Center at Houston, this study aims to evaluate whether psilocybin-assisted psychotherapy is a feasible and safe treatment for BD-II depression, particularly for those at risk of passive suicidal ideation but without an active intent to act.

Participants will receive two doses of 25 mg psilocybin, spaced four weeks apart, alongside mindfulness-based cognitive behavioural therapy (M-CBT), incorporating preparatory and integration sessions. Researchers will assess changes in suicidality, depression severity, and acute psychedelic experiences using validated clinical scales, such as the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Columbia-Suicide Severity Rating Scale (C-SSRS). The study is expected to begin in January 2025 and complete by January 2027. If successful, the findings could inform novel therapeutic approaches for BD-II patients with limited treatment options for suicidality.

Trial Details

This study aims to determine whether psilocybin paired with psychotherapy is a safe, feasible, and acceptable treatment for Bipolar II (BD II) depression, specifically, individuals experiencing suicidal ideation (without having an active plan or intention to act). The design is a non-randomized clinical trial, where patients will receive up to 2 doses of 25mg psilocybin in the context of psychological support informed by mindfulness-based CBT and typical elements of psychedelic treatments (e.g., preparation, intention setting, integration). The investigators will measure suicidality, depression, and acute experiences using validated questionnaires at multiple time points in the study. If this study shows psilocybin to be a feasible, acceptable, and safe treatment option, this would have huge implications for improving outcomes because highly effective treatment for suicidality in patients with Bipolar Disorder is still lacking.

Trial Number NCT06706232

Data attribution

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