A Phase 2 Sequential Dose-Finding Study of Preparation for Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Safety and Feasibility measures
研究概览
简要总结
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression and loss of meaning during the past 5 years. Each participant will be in a group cohort of 8, and 3 cohorts will be tested at each dose level. The objectives are safety, feasibility, mechanism testing, and outcomes.
详细描述
This is a single-arm study that examines the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation.
Population: Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression (PHQ-9 ≥10) and loss of meaning during the past 5 years.
Study Design: Phase 2, non-randomized, sequential cohort dose-escalation study examining the optimal number of preparation sessions for group retreat psilocybin therapy. Three cohorts will receive different "doses" of preparation: Cohort 1 receives 7 total preparation sessions (6 virtual + 1 in-person), Cohort 2 receives 4 total preparation sessions (3 virtual + 1 in-person), and Cohort 3 receives 2 total preparation sessions (1 virtual + 1 in-person). Each cohort includes 3 retreats with 8 participants per retreat.
Sample Size: 72 participants total (24 per cohort, distributed across 3 retreats of 8 participants each) Study Duration: 18-24 months from enrollment of first participant to completion of final data analysis. Individual participant involvement spans approximately 8-10 months including 6-month post-retreat follow-up.
Primary Objectives: (1) Safety: Assess incidence and severity of challenging experiences and adverse events across preparation dose levels using the Challenging Experience Questionnaire (CEQ), adverse event monitoring, and psychiatric symptom scales (PHQ-9, GAD-7, C-SSRS). (2) Feasibility: Determine completion rates for preparation sessions at each dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) currently in clinical practice
- •Age 25-70 years
- •Loss of meaning single question "I used to find deep meaning in my work as a healthcare clinician, but during the past 5 years that sense of meaning has faded".
- •PHQ-9 score ≥10 (moderate symptoms of depression)
- •Ability to commit to all preparation sessions and retreat attendance
- •English fluency sufficient for group participation
- •Screening laboratory tests within acceptable limits, including liver function tests
- •Negative urine drug screen for non-prescribed psychoactive medications.
- •ECG with QTc <450 ms
- •Willing to taper and discontinue any supplements with serotonin-like properties, including but not limited to 5-HTP, St. John's Wort, and 'brain food' supplements.
- •For participants of childbearing potential, agree to use to use highly effective contraception. Highly effective contraceptive methods are defined as those that, alone or in combination, result in a low failure rate (less than 1 percent per year), including but not limited to implants, IUDs, contraceptive injections, or contraceptive pills.
排除标准
- •Personal or first-degree family history of psychotic disorder or bipolar I disorder
- •Personal major depressive episode prior to entering healthcare as a professional
- •Active suicidal ideation with intent or plan
- •Unstable medical conditions
- •Pregnancy or breastfeeding
- •Hypertension with BP systolic >150 or diastolic > 90
研究组 & 干预措施
Group Retreat Psilocybin Therapy
In this non-randomized trial, the dose of psilocybin will be as follows: for participants not taking an antidepressant, the dose will be psilocybin 25 mg + optional booster 10 mg; for participants who are taking an antidepressant the dose will be psilocybin 35 mg + optional booster 10 mg,
干预措施: Psilocybin (Drug)
结局指标
主要结局
Safety and Feasibility measures
时间窗: 1 week, 1 month, and 3 months after the retreat.
Adverse events
次要结局
- Mechanism testing measures(3rd day of retreat)
- Exploratory symptom measures(1 week, 1 month, and 3 months after the retreat.)
- Symptom measures(1 week, 1 month, and 3 months after the retreat.)
研究者
Anthony Back MD
Professor: Division of Hematology and Oncology
University of Washington