The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
研究概览
简要总结
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
详细描述
This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low ("microdose") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures. After posting of these trial results, this data will be combined with the data from the trial at Yale University (NCT07610369) for publication purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
This trial is testing various doses of psilocybin. Participants, study staff and clinical assessors will be blinded to individual treatment conditions until study close-out. The clinician administered instruments will be administered by different clinical study staff than the facilitators who provide the preparation, psilocybin therapy, and integration sessions.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 80
- •Comfortable speaking and writing in English
- •Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)
- •Currently experiencing depressive symptoms
- •Able to attend all in-person visits at UCSF as well as virtual visits
- •Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating
排除标准
- •Psychotic symptoms involving loss of insight
- •Significant cognitive impairment
- •Regular use of medications that may have problematic interactions with psilocybin
- •A health condition that makes this study unsafe or unfeasible, determined by study physicians
研究组 & 干预措施
Psilocybin Administration Session 1
Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after.
干预措施: Pimavanserin (Drug)
Psilocybin Administration Session 2
Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after.
干预措施: Psilocybin (Drug)
Psilocybin Administration Session 2
Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after.
干预措施: Pimavanserin (Drug)
Psilocybin Administration Session 1
Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
时间窗: Baseline to 30 days after first drug dose
Changes in depression as measured by the MADRS
次要结局
- Participant-reported acceptability of study procedures(30 days after second drug dose)
- Care partner/support person reported distress(Baseline to 90 days after second drug dose)
- Changes in depression severity(7 days after first drug dose to 90 days after second drug dose)
- Changes in Quality of Life(Baseline to 90 days after second drug dose)
- Changes in clinician-assessed depression(Baseline to 90 days after second drug dose)
- Changes in anxiety(Baseline to 90 days after second drug dose)
- Changes in PD symptom severity(Baseline to 90 days after second drug dose)
- Changes in cognitive performance(Baseline to 90 days after second drug dose)
- Safety and tolerability of psilocybin therapy for depression in people with PD(Baseline to 90 days after second drug dose)
- Changes in clinician-rated psychotic symptoms(Baseline to 90 days after second drug dose)
- Subjective effects of psilocybin(Up to 30 and 60 days after Baseline)
研究者
Joshua Woolley, MD, PhD
Principal Investigator
University of California, San Francisco