NCT00467454撤回2 期
A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
研究概览
简要总结
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.
详细描述
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in pyromania. Ten subjects with DSM-IV pyromania will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to set fires patients with pyromania. 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
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women age 16-75;
- •current DSM-IV pyromania
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 within 3 months prior to study baseline;
- •initiation of a psychotropic medication within 2 months prior to study inclusion;
- •previous treatment with naltrexone; and
- •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
1
Active Comparator
Naltrexone
干预措施: Naltrexone (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
时间窗: At each visit
次要结局
- Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory(At each visit)
研究者
研究点 (1)
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