Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
研究概览
简要总结
In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period.
详细描述
In this pilot study, up to 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Procedures will follow those previously established in depression studies of psilocybin. Patients will receive intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the day of medication administration in the Biological Studies Unit of New York State Psychiatric Institute. Followup visits to monitor safety and clinical outcome will be conducted at day 1, week1, and months 1,2, and 3 post-administration. Resting state function magnetic resonance imaging will be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain circuits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body dysmorphic disorder of at least moderate severity, non-delusional subtype, for >6 months
- •History of intolerance of, or nonresponse to, a prior adequate trial of a serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
- •Currently in psychotherapy (other than cognitive behavioral therapy (CBT) for body dysmorphic disorder
排除标准
- •Current major depressive disorder of greater than moderate severity
- •Other significant psychiatric or medical comorbidity or conditions that could interfere with safety of participation or interpretation of outcomes
- •Use of: investigational medication within 3 months of baseline; depot antipsychotic within 6 months of baseline; serotonergic medication within 2 weeks of baseline (6 weeks for fluoxetine).
- •Females who are pregnant, breastfeeding, or sexually active and not willing to use adequate contraception
- •Enrollment in any investigational drug or device study in past 30 days
- •Prior adverse effects from psilocybin
研究组 & 干预措施
Psilocybin
A single dose of Psilocybin 25mg p.o.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
时间窗: From baseline (day -1) up to 3 months post-dose
The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms.
次要结局
未报告次要终点
研究者
Franklin Schneier
Professor of Clinical Psychiatry
New York State Psychiatric Institute