BMJ openJul 13, 2026

Safety and acceptability of two psilocybin doses in bipolar II depression: plan for an open-label feasibility study

Psychedelic Science Weekly Brief ↗PubMed ↗DOI ↗OA ↗

Updated Jul 14, 2026

Abstract

A study protocol aims to explore the acceptability and safety of psilocybin-assisted therapy in patients with Bipolar II disorder and suicidal ideation.

Bipolar II disorder is characterized by episodes of hypomania and depression, with depression often leading to suicidality.
Current pharmacological treatments for chronic depression and suicidal ideation in this population remain largely ineffective.
Psilocybin may offer an alternative treatment pathway, despite individuals with bipolar disorder typically being excluded from related research due to safety concerns.
The study will assess patient preferences regarding psilocybin-assisted therapy, focusing on its acceptability and safety.

Simplified

Bipolar II disorder (BD-II) is characterised by hypomanic and depressive episodes with the latter tending to dominate the clinical course of the disorder, and they are often associated with suicidality. Despite available guideline-based recommendations for first-line pharmacological treatments, patient outcomes remain suboptimal, especially for those with chronic depression and suicidal ideation. The dearth of viable treatment options for this population is evident, which is where psychedelics propose an additional alternative path. Psilocybin has recently shown promise in treating major depressive disorder and treatment-resistant depression; however, individuals with bipolar disorder or suicidality are typically excluded from such trials due to safety concerns (ie, risk of emerging suicidal behaviour, psychosis and/or mania). Here, we present the protocol of a study which aims to explore the acceptability, safety and treatment preferences of psilocybin-assisted therapy in patients with BD-II struggling with suicidal ideation.

Full Text

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Funding

Competing interests

Competing interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: TDM: Compass Pathways (free access to COMP360 for this open label feasibility study and Mentor for the COMP006 therapists at all sites in Germany); JCS: Alkermes (Advisory Board), Compass Pathways (Research Grant), Johnson & Johnson (Consultant), MindMed (Research Grant), Relmada Therapeutics, Inc. (Research Grant), Sunovion (Consultant); JQ: Consultant for LivaNova, Neumora Therapeutics, and Johnson & Johnson; holds copyrights for books published by Artmed Editora, Artmed Panamericana, and Elsevier/Academic Press. All other authors have no competing interests to declare.

PubMed

Safety and acceptability of two psilocybin doses in bipolar II depression: plan for an open-label feasibility study

Abstract

Full Text

Funding

Competing interests

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