NCT00269594已完成2 期
An Open-Label Study of Lamictal In Neurotic Excoriation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
研究概览
简要总结
The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and well tolerated 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •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 and
- •patients who have previously been diagnosed with a medical condition that cause skin itchiness (e.g. liver, kidney, and blood diseases, etopic allergies)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
次要结局
- Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
研究者
研究点 (2)
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