Psilocybin Therapy for Depression in Bipolar II Disorder

NCT05065294 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-32789
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar II Disorder

Keywords

Bipolar; Depression; Psilocybin; Psychedelic; Psilocybin Therapy; Bipolar II; Safety

Outcome Measures

Primary Outcomes (8)

• 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)

  Baseline to 3 months following last drug dose

• Recruitment rate

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

  Baseline to 3 months following last drug dose

• Retention rate

  -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

  * 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

  * 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

  * 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

  * 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

  * 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 Outcomes (9)

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

  Baseline to 3 months following last drug dose

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

  Baseline to 3 months following last drug dose

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

  Baseline to 3 months following last drug dose

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

  Baseline to 3 months following last drug dose

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

  Baseline to 3 months following last drug dose

Study Arms (1)

Psilocybin therapy

EXPERIMENTAL

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

Interventions

Psilocybin therapy DRUG

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

Also known as: 4-phosphoryloxy-N,N-dimethyltryptamine

Psilocybin therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94121, United States

Location

Related Publications (5)

• Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2016 Apr 9;387(10027):1561-1572. doi: 10.1016/S0140-6736(15)00241-X. Epub 2015 Sep 18.

  PMID: 26388529 BACKGROUND

• Carhart-Harris RL, Bolstridge M, Rucker J, Day CM, Erritzoe D, Kaelen M, Bloomfield M, Rickard JA, Forbes B, Feilding A, Taylor D, Pilling S, Curran VH, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Lancet Psychiatry. 2016 Jul;3(7):619-27. doi: 10.1016/S2215-0366(16)30065-7. Epub 2016 May 17.

  PMID: 27210031 BACKGROUND

• Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8.

  PMID: 29119217 BACKGROUND

• Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.

  PMID: 27909165 BACKGROUND

• Szmulewicz AG, Angriman F, Samame C, Ferraris A, Vigo D, Strejilevich SA. Dopaminergic agents in the treatment of bipolar depression: a systematic review and meta-analysis. Acta Psychiatr Scand. 2017 Jun;135(6):527-538. doi: 10.1111/acps.12712. Epub 2017 Mar 3.

  PMID: 28256707 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Joshua D Woolley, MD,PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• David Guard, PhD

  San Francisco State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Open-label, single-arm, pilot study

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 4, 2021
• Study Start: January 28, 2022
• Primary Completion: August 1, 2024
• Study Completion: July 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)