A Double-Blind Study of Lamictal in Neurotic Excoriation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
研究概览
简要总结
The goal of the proposed study is to evaluate the comparative efficacy of Lamictal (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective than placebo in patients with neurotic excoriation. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
详细描述
The study will consist of 12 weeks of double-blind treatment with Lamictal (lamotrigine) compared to placebo (1:1) in 30 subjects with neurotic excoriation.
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 diagnosis of neurotic excoriation.
排除标准
- •unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
- •history of seizures;
- •myocardial infarction within 6 months;
- •current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- •a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal;
- •clinically significant suicidality;
- •lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- •current or recent (past 3 months) DSM-IV substance abuse or dependence;
- •illegal substance use within 2 weeks of study initiation;
- •initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
- •previous treatment with Lamictal (lamotrigine);
- •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;
- •current treatment with an anti-epileptic medication.
研究组 & 干预措施
1
Lamictal (lamotrigine)
干预措施: Lamictal (lamotrigine) (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
时间窗: beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).
次要结局
未报告次要终点