NCT00182507已完成4 期
A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Clinical Global Impression (CGI)-Improvement Scale ≤ 2
研究概览
简要总结
Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been unsuccessful. Tics/Tourrettes' Syndrome (TS) is a disorder, which appears to be related to TTM, but is treated with a different class of medications than used in OCD, namely antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine in the treatment of hair pulling.
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
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
- •primary DSM-IV trichotillomania; CGI-Severity ≥ 4
排除标准
- •Any other Axis I primary diagnosis; CGI-S < 4; current comorbid: OCD, MDD, alcohol or substance abuse; lifetime hx of: schizophrenia, bipolar affective disorder or dementia; current pregnancy/lactation; current suicidality or homicidality; major medical problems or clinically unstable medical disease; hx of: seizures, stroke or head trauma; prior use of neuroleptics
结局指标
主要结局
Clinical Global Impression (CGI)-Improvement Scale ≤ 2
次要结局
- CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale
研究者
研究点 (2)
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