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Psilocybin Therapy for Depression in Bipolar II Disorder (BAP)

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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

Tracking Information
First Submitted Date  ICMJE September 14, 2021
First Posted Date  ICMJE October 4, 2021
Last Update Posted Date October 4, 2021
Estimated Study Start Date  ICMJE November 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2021)
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin Therapy for Depression in Bipolar II Disorder
Official Title  ICMJE An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label, single-arm, pilot study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Bipolar II Disorder
Intervention  ICMJE Drug: Psilocybin therapy
- Psilocybin administration session 10mg-25mg delivered orally with psychological support and monitoring
Other Name: 4-phosphoryloxy-N,N-dimethyltryptamine
Study Arms  ICMJE 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.
Intervention: Drug: Psilocybin therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2021)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kimberly Sakai 415-221-4810 ext 24074 PsilocybinStudies@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05065294
Other Study ID Numbers  ICMJE 20-32789
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joshua Woolley, MD/PhD, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua D Woolley, MD,PhD University of California, San Francisco
Study Director: David Guard, PhD San Francisco State University
PRS Account University of California, San Francisco
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP