An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of psilocybin therapy for depression in BD II
Study Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Psilocybin therapy
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.
Intervention: Psilocybin therapy (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of psilocybin therapy for depression in BD II
Time Frame: Baseline to 3 months following last drug dose
-Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Recruitment rate
Time Frame: Baseline to 3 months following last drug dose
-Measured as a percentage of participants who were contacted for pre-screening and consented.
Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II
Time Frame: Baseline to 3 months following last drug dose
* Columbia-Suicide Severity Rating Scale (C-SSRS) * Characterizes suicidal ideation in three separate categories with a total score range from 0-25 * Higher scores indicate greater severity
Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II
Time Frame: Baseline to 11 days following each drug dose
* Altman Self-Rating Mania Scale(ASRM-14) * Each item rated on a 0 to 4 scale, with a total score of 0 to 56 * Higher scores indicating greater severity of manic symptoms, with items that also measure psychosis
Retention rate
Time Frame: Baseline to 3 months following last drug dose
-Measured as a percentage of participants who began and completed treatment.
Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II
Time Frame: Baseline to 3 weeks following last drug dose
* Montgomery-Asberg Depression Rating Scale (MADRS) * Each item is scored on a on a scale of 0-6 with a total score of 0-60 * Higher scores correspond to worse outcomes
Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II
Time Frame: Baseline to 3 months following each drug dose
* Young Mania Scale(YMS) * 7 items are rated on a 0 to 4 scale and 4 items are rated on a 0 to 8 scale. The total score ranges from 0-60 * Higher scores indicating greater severity of manic symptoms.
Treatment Satisfaction of study procedures
Time Frame: Baseline to 3 months following last drug dose
* Measured by the treatment satisfaction questionnaire * 5-item scale, plus three free response questions * Higher scores representing better treatment satisfaction
Secondary Outcomes
- 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)
- Patient reported effects of psilocybin therapy on depressive symptoms 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(3 weeks following last drug dose)
Investigators
Joshua Woolley, MD, PhD
Assistant Professor
University of California, San Francisco