Silymarin Treatment of Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
研究概览
简要总结
The proposed study will consist of a 9 week double-blind cross-over study trial of milk thistle in 15 people (ages 18-65). The study will be divided into an initial 4 week phase, a one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting of active treatment with milk thistle, and the other 4 week phase consisting of inactive placebo treatment. Participants will be randomized to receive either milk thistle or placebo during the first 4 week phase on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
详细描述
The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in adults with body dysmorphic disorder. The hypothesis to be tested is that silymarin will be more effective and well tolerated in adults with body dysmorphic disorder compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
The primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using silymarin (milk thistle) in 15 participants with body dysmorphic disorder. The study will consist of three phases: a 4 week active treatment phase with milk thistle, a 4 week placebo phase, and a one week wash out phase between the active and placebo phases. The subjects will be randomized to either receive active or placebo treatment in the first 4 weeks, and the other during the remaining 4 week phase.
This will be one of few studies assessing the use of pharmacotherapy for the treatment of body dysmorphic disorder in adults. Assessing the efficacy and safety of silymarin (milk thistle), will help inform clinicians about additional treatment options for adults suffering from this disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 18-65
- •Diagnosis of current body dysmorphic disorder (BDD) based on DSM-5 criteria and confirmed using the clinician-administered Structural Clinical Interview for DSM-5 (SCID)
- •Able and willing to provide written consent for participation
排除标准
- •Unstable medical illness as determined by the investigator
- •History of seizures
- •Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale)
- •Baseline score greater than or equal to 17 on the Hamilton Depression Rating Scale (17-item HDRS)
- •Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder
- •Initiation of psychotherapy of behavior therapy within 3 months prior to study baseline
- •Previous treatment with milk thistle
- •Any history of psychiatric hospitalization in the past year
- •Currently pregnant (confirmed by urine pregnancy test)
研究组 & 干预措施
Silymarin (Milk Thistle)
Each subject will have a 4 week treatment phase with milk thistle.
干预措施: Milk Thistle (Drug)
Placebo
4 week placebo phase before or after milk thistle phase depending on randomization.
干预措施: Placebo (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
时间窗: Baseline and 9 weeks
The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will take the BDD-YBOCS. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses severity of body dysmorphic disorder symptoms.
次要结局
- Clinical Global Impression- Severity and Improvement (CGI)(Baseline and 9 weeks)
- Hamilton Anxiety Rating Scale (HAM-A)(Baseline and 9 weeks)
- Hamilton Depression Rating Scale (HAM-D)(Baseline and 9 weeks)
- Sheehan Disability Scale (SDS)(Baseline and 9 weeks)