A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Massachusetts General Hospital Hairpulling Scale
研究概览
简要总结
This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania
详细描述
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women age 18-65;
- •current DSM-IV trichotillomania
排除标准
- •unstable medical illness;
- •history of seizures;
- •myocardial infarction within 6 months;
- •current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- •any thoughts of suicide;
- •lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- •previous treatment with N-Acetyl Cysteine;
- •treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
- •diagnosis of asthma
研究组 & 干预措施
N-Acetyl Cysteine
N-Acetyl Cysteine
干预措施: N-Acetyl Cysteine (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Massachusetts General Hospital Hairpulling Scale
时间窗: Baseline and final visit after 12 weeks
There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.
次要结局
未报告次要终点