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临床试验/NCT05065294
NCT05065294进行中(未招募)2 期

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

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年1月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
14
试验地点
1
主要终点
Safety and tolerability of psilocybin therapy for depression in BD II

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Psilocybin therapy (Drug)

结局指标

主要结局

Safety and tolerability of psilocybin therapy for depression in BD II

时间窗: 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

时间窗: Baseline to 3 months following last drug dose

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

Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II

时间窗: 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

Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II

时间窗: 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

Retention rate

时间窗: 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

时间窗: 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

Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II

时间窗: 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.

Treatment Satisfaction of study procedures

时间窗: 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

次要结局

  • 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)
  • 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 adult attachment in people with Bipolar II (exploratory)(Baseline to 3 months following last drug dose)
  • Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)(Baseline to 3 months following last drug dose)
  • Subjective effects of psilocybin therapy in people with Bipolar II(3 weeks following last drug dose)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Woolley, MD, PhD

Assistant Professor

University of California, San Francisco

研究点 (1)

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