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OpenTrials
Active, Not Recruiting

NCT Number: NCT05065294

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bipolar II Disorder Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Francisco

San Francisco, California, 94121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin therapy

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

Other names: 4-phosphoryloxy-N,N-dimethyltryptamine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: BAP

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 4, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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