A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
研究概览
简要总结
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
详细描述
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. 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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women age 21-75
- •current DSM-IV kleptomania.
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
- •clinically significant suicidality
- •current or recent (past 3 months) DSM-IV substance abuse or dependence
- •illegal substance within 2 weeks of study initiation
- •initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline
- •initiation of a psychotropic medication within 2 months prior to study inclusion
- •previous treatment with naltrexone
- •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.
研究组 & 干预措施
A
Naltrexone
干预措施: Naltrexone (Drug)
B
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
时间窗: K-YBOCS is done at each visit by the investigator.
The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).
次要结局
未报告次要终点