A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
研究概览
简要总结
The purpose of the study is to conduct a double-blind, placebo-controlled study of D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria
- •BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24
- •Females of childbearing potential must have a negative urinary beta-HCG test
- •Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures
排除标准
- •Pregnant or breastfeeding women will be excluded
- •People taking medications that may interfere with DCS
- •History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- •Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern.
- •Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem
- •Those deemed to pose a serious suicidal or homicidal threat will be excluded
- •Current psychotherapy or failure to benefit from ten or more sessions of previous ERP treatment is a rule-out
研究组 & 干预措施
D-cycloserine
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
干预措施: d-cycloserine (Drug)
Placebo
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
时间窗: Mid-treatment (week 6)
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.
次要结局
未报告次要终点
研究者
Sabine Wilhelm, PhD
PhD
Massachusetts General Hospital