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The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.
The primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder (BD II). Fourteen participants, ages 18 to 70 with clinically diagnosed BD II with active depression, in active outpatient mental health treatment, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by an initial drug administration of oral psilocybin,supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will complete assessment and integration sessions with the facilitators subsequently in order to help process the experience. Participants who tolerated the first dosage may be asked to complete a second psilocybin dosing session, involving the same preparation, procedures, integration, and supervision as the first. Primary outcome measures will assess safety, tolerability, and feasibility of study procedures. Efficacy will be measured by change in depression as measured by the MADRS three weeks after the final psilocybin administration. Exploratory outcome measures will assess changes in sleep, quality of life, and therapeutic engagement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin therapy | Experimental | Participants will receive one or two doses of psilocybin in a monitored setting approximately three weeks apart, with preparation sessions before and integration sessions after. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin therapy | Drug | - Psilocybin administration session 10mg-25mg delivered orally with psychological support and monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of psilocybin therapy for depression in BD II | -Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs) | Baseline to 3 months following last drug dose |
| Recruitment rate | -Measured as a percentage of participants who were contacted for pre-screening and consented. | Baseline to 3 months following last drug dose |
| Retention rate | -Measured as a percentage of participants who began and completed treatment. | Baseline to 3 months following last drug dose |
| Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II |
| Baseline to 3 weeks following last drug dose |
| Treatment Satisfaction of study procedures |
| Baseline to 3 months following last drug dose |
| Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory) |
| Baseline to 3 months following last drug dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua D Woolley, MD,PhD | University of California, San Francisco | Principal Investigator |
| David Guard, PhD | San Francisco State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26388529 | Background | Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2016 Apr 9;387(10027):1561-1572. doi: 10.1016/S0140-6736(15)00241-X. Epub 2015 Sep 18. | |
| 27210031 | Background | Carhart-Harris RL, Bolstridge M, Rucker J, Day CM, Erritzoe D, Kaelen M, Bloomfield M, Rickard JA, Forbes B, Feilding A, Taylor D, Pilling S, Curran VH, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Lancet Psychiatry. 2016 Jul;3(7):619-27. doi: 10.1016/S2215-0366(16)30065-7. Epub 2016 May 17. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 14, 2025 | Jul 31, 2025 | 5 | ||
| Dec 29, 2025 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Open-label, single-arm, pilot study
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| Baseline to 11 days following each drug dose |
| Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II |
| Baseline to 3 months following each drug dose |
| Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II |
| Baseline to 3 months following last drug dose |
| Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory) |
|
| Baseline to 3 months following last drug dose |
| Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory) |
| Baseline to 3 months following last drug dose |
| Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory) |
| Baseline to 3 months following last drug dose |
| Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory) |
| Baseline to 3 months following last drug dose |
| Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory) |
| Baseline to 3 months following last drug dose |
| Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory) |
| Baseline to 3 months following last drug dose |
| Subjective effects of psilocybin therapy in people with Bipolar II |
| Baseline to 3 months following last drug dose |
| Subjective effects of psilocybin therapy in people with Bipolar II |
| 3 weeks following last drug dose |
| 29119217 | Background | Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8. |
| 27909165 | Background | Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513. |
| 28256707 | Background | Szmulewicz AG, Angriman F, Samame C, Ferraris A, Vigo D, Strejilevich SA. Dopaminergic agents in the treatment of bipolar depression: a systematic review and meta-analysis. Acta Psychiatr Scand. 2017 Jun;135(6):527-538. doi: 10.1111/acps.12712. Epub 2017 Mar 3. |
| Jan 16, 2026 |
| 6 |
| D001519 |
| Behavior |