Psilocybin Therapy for Depression in Bipolar II Disorder

Phase 2Active Not RecruitingNCT05065294

University of California, San Francisco14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bipolar II Disorder

Interventions

Psilocybin therapyDRUG

\- Psilocybin administration session 10mg-25mg delivered orally with psychological support and monitoring

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

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)

Time frame: Baseline to 3 months following last drug dose

Recruitment rate

-Measured as a percentage of participants who were contacted for pre-screening and consented.

Time frame: Baseline to 3 months following last drug dose

Retention rate

-Measured as a percentage of participants who began and completed treatment.

Time frame: Baseline to 3 months following last drug dose

Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II

* 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

Time frame: Baseline to 3 weeks following last drug dose

Treatment Satisfaction of study procedures

* Measured by the treatment satisfaction questionnaire * 5-item scale, plus three free response questions * Higher scores representing better treatment satisfaction

Time frame: 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

* 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

Time frame: Baseline to 11 days following each drug dose

Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory)

* Quick Inventory of Depressive Symptomatology (QIDS-SR) * Each item is scored on a on a scale of 0-3, with a total score of 0-27 * Higher scores correspond to worse outcomes

Time frame: Baseline to 3 months following last drug dose

Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)

* Generalized Anxiety Disorder 7-item scale (GAD-7) * Each item is rated on a scale from 0-3, with a total score of 0-21 * Higher scores correspond to worse outcomes

Time frame: Baseline to 3 months following last drug dose

Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory)

* Insomnia Severity Index (ISI) * Each item is scored on a scale of 0-4 with a total score range of 0-28 * Higher scores indicate greater severity in sleep disturbance

Time frame: Baseline to 3 months following last drug dose

Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory)

* Quality of Life in Bipolar Disorder Questionnaire (QoL-BD) * Each item is scored on a scale of 1-5 with a total score range of 48-240 * Higher scores indicate greater quality of life

Time frame: Baseline to 3 months following last drug dose

Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)

* Zanarini Rating Scale (ZRS) * Each item is scored on a scale of 0-4 with a total score range of 0-30 * Higher scores indicate greater severity in symptoms

Time frame: Baseline to 3 months following last drug dose

Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)

* Experiences in Close Relationships-Modified 16-Item Scale (ECR-M16) * Each item is scored on a scale of 1-7 with a total score range of 8-126 * Lower scores on each dimension of attachment anxiety and avoidance represent greater levels of attachment security

Time frame: Baseline to 3 months following last drug dose

Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)

* Bipolar Recovery Questionnaire (BRQ) * 36 items (visual analog scales) * Higher total scores indicate a higher degree

Time frame: Baseline to 3 months following last drug dose

Subjective effects of psilocybin therapy in people with Bipolar II

* 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) * 94 items (visual analog scales) broken down into subcategories to quantify the acute subjective effects of psilocybin directly following each psilocybin administration session

Time frame: Baseline to 3 months following last drug dose

Subjective effects of psilocybin therapy in people with Bipolar II

* Study specific Transformational Experiences Questionnaire (TEQ) * Meant to quantify subjective effects of psilocybin on 1-7 scale

Time frame: 3 weeks following last drug dose