Memantine Treatment of Kleptomania: An Open-Label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
研究概览
简要总结
The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.
详细描述
The proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with kleptomania. The hypothesis to be tested is that memantine 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
- Na
- 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
- 否
入选标准
- •men and women age 18-65
- •current KM using the clinician-administered Structured Clinical Interview for Kleptomania (SCI-K)
- •stealing behavior within 2 weeks prior to enrollment.
排除标准
- •infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for kleptomania (KM)
- •unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen
- •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 memantine with possible psychotropic effects or unfavorable interactions
- •clinically significant suicidality
- •current Axis I disorder determined by the Structured Clinical Interview for the DSM (SCID) and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence
- •lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID
- •current or recent (past 3 months) DSM-IV substance abuse or dependence
- •positive urine drug screen at screening
- •initiation of psychotherapy or behavior therapy within 3 months prior to study baseline
- •previous treatment with memantine; and 14) 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
Memantine
Memantine 10-30mg
干预措施: Memantine (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
时间窗: Week 8 (last visit)
Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS) was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
次要结局
- Kleptomania Symptom Assessment Scale (K-SAS)(Week 8 (last visit))
- Clinical Global Impression Severity Scales (CGI)(Week 8 (last visit))