Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psilocybin Therapy for Depression in Bipolar II Disorder (BAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05065294
Recruitment Status : Not yet recruiting
First Posted : October 4, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Joshua Woolley, MD/PhD, University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Bipolar II Disorder Drug: Psilocybin therapy Phase 2

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 30 to 65 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single-arm, pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 4-phosphoryloxy-N,N-dimethyltryptamine




Primary Outcome Measures :
  1. 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)

  2. 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.

  3. Retention rate [ Time Frame: Baseline to 3 months following last drug dose ]
    -Measured as a percentage of participants who began and completed treatment.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 30 to 65
  • 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 two previous medication trials for their bipolar disorder, each lasting at 6 weeks or more.
  • Have an established mental health care provider who is seen at least twice a month

Exclusion Criteria:

  • Current or previous diagnosis of Bipolar I Disorder
  • History of schizophrenia spectrum or psychotic disorder
  • Use of psychedelics within the past 12 months, including MDMA and Ketamine
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065294


Contacts
Layout table for location contacts
Contact: Kimberly Sakai 415-221-4810 ext 24074 PsilocybinStudies@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco
San Francisco, California, United States, 94121
Contact: Kimberly Sakai    415-221-4810 ext 24074    psilocybinstudies.@ucsf.edu   
Principal Investigator: Joshua D Woolley, MD,PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Joshua D Woolley, MD,PhD University of California, San Francisco
Study Director: David Guard, PhD San Francisco State University
  Study Documents (Full-Text)

Documents provided by Joshua Woolley, MD/PhD, University of California, San Francisco:
Informed Consent Form  [PDF] February 10, 2021

Publications:

Layout table for additonal information
Responsible Party: Joshua Woolley, MD/PhD, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05065294    
Other Study ID Numbers: 20-32789
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua Woolley, MD/PhD, University of California, San Francisco:
Bipolar
Depression
Psilocybin
Psychedelic
Psilocybin Therapy
Bipolar II
Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms
Psilocybin
N,N-Dimethyltryptamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists