Psilocybin Therapy for Depression in Bipolar II Disorder (BAP)
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.
Detailed Description
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.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Psilocybin therapy
experimentalOne- or two-dose open-label psilocybin therapy with preparatory and integration sessions.
Interventions
- Psilocybin10 - 25 mgvia Oral• one or two sessions• 2 doses total
10–25 mg oral; second dose optional ~3 weeks after the first; psychological support and clinician safety monitoring.
Participants
Inclusion Criteria
- Inclusion Criteria:
- Age 18 to 70
- Comfortable speaking and writing in English
- Diagnosis of Bipolar Disorder II with current depression
- Have a care partner/support person available throughout the study
- Able to attend all in-person visits at UCSF as well as virtual visits
- Having tried at least one previous medication trials for their bipolar disorder, each lasting at 6 weeks or more.
Exclusion Criteria
- Exclusion Criteria:
- Current or previous diagnosis of Bipolar I Disorder
- History of schizophrenia spectrum or psychotic disorder
- Use of psychedelics within the past 6 months, including MDMA
- Current diagnosis of cancer
- Seizures that continue to the present
- Fear of blood or needles
- Regular use of medications that may have problematic interactions with psilocybin, including but not limited to antidepressants (Bupropion allowed), serotonin antagonists, some antipsychotics, dopamine agonists/antagonists, stimulants, opioids, and Lithium.
- A health condition that makes this study unsafe or unfeasible, determined by study physicians
Primary Results(1 publication)
Participants
Response Rates
MADRS ≤ 6 (remission)
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Psilocybin therapyexperimental | 14 | 9(64.3%) | 0(0.0%) | 0(0.0%) | 1(7.1%) |
| Psilocybin therapyexperimental | 14 | 6(42.9%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| Psilocybin therapyexperimental | 14 | 3(21.4%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| Psilocybin therapyexperimental | 14 | 5(35.7%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| Psilocybin therapyexperimental | 14 | 1(7.1%) | 1(7.1%) | 0(0.0%) | 0(0.0%) |
* Includes 10mg and 25mg doses. 3 psychiatric AEs: 1 active suicidal ideation (severe), 1 passive suicidal ideation, 1 hypomania. 1 participant withdrew (discontinued) after 10mg session.
* Counts for 10mg and 25mg combined as per Table 2.
* Includes 1 hypomania event.
* 1 severe AE (worsening suicidal ideation) reported 37 days post-10mg session. Not classified as SAE per study note.
Study Details
- StatusActive not recruiting
- PhasePhase II
- Typeinterventional
- DesignNon-randomized
- Target Enrollment14 participants
- TimelineStart: 2021-11-11End: 2023-09-09
- Compound
- Topic
Study Team
Sponsors & Collaborators
- University of California, San FranciscoPrimary Sponsor