Psilocybin Therapy for Depression in Bipolar II Disorder (BAP)

September 23, 2024 updated by: Joshua Woolley, MD, PhD, University of California, San Francisco

An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with Bipolar II Disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Psilocybin therapy
- Psilocybin administration session 10mg-25mg delivered orally with psychological support and monitoring
Other Names:
  • 4-phosphoryloxy-N,N-dimethyltryptamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline to 3 months following last drug dose
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.
Baseline to 3 months following last drug dose
Retention rate
Time Frame: Baseline to 3 months following last drug dose
-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
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
Baseline to 3 weeks following last drug dose
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
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
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
Baseline to 11 days following each drug dose
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.
Baseline to 3 months following each drug dose
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
Baseline to 3 months following last drug dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory)
Time Frame: Baseline to 3 months following last drug dose
  • 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
Baseline to 3 months following last drug dose
Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)
Time Frame: Baseline to 3 months following last drug dose
  • 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
Baseline to 3 months following last drug dose
Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory)
Time Frame: Baseline to 3 months following last drug dose
  • 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
Baseline to 3 months following last drug dose
Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory)
Time Frame: Baseline to 3 months following last drug dose
  • 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
Baseline to 3 months following last drug dose
Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)
Time Frame: Baseline to 3 months following last drug dose
  • 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
Baseline to 3 months following last drug dose
Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)
Time Frame: Baseline to 3 months following last drug dose
  • 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
Baseline to 3 months following last drug dose
Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)
Time Frame: Baseline to 3 months following last drug dose
  • Bipolar Recovery Questionnaire (BRQ)
  • 36 items (visual analog scales)
  • Higher total scores indicate a higher degree
Baseline to 3 months following last drug dose
Subjective effects of psilocybin therapy in people with Bipolar II
Time Frame: Baseline to 3 months following last drug dose
  • 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
Baseline to 3 months following last drug dose
Subjective effects of psilocybin therapy in people with Bipolar II
Time Frame: 3 weeks following last drug dose
  • Study specific Transformational Experiences Questionnaire (TEQ)
  • Meant to quantify subjective effects of psilocybin on 1-7 scale
3 weeks following last drug dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joshua D Woolley, MD,PhD, University of California, San Francisco
  • Study Director: David Guard, PhD, San Francisco State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-32789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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