Memantine Treatment of Compulsive Buying: An Open-Label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)
研究概览
简要总结
This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.
详细描述
The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of compulsive buying. Sixteen subjects meeting criteria for compulsive buying will receive 8 weeks of open-label memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with compulsive buying. 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 CB using the clinician-administered Structured Clinical Interview for Compulsive buying (SCI-CB)
- •buying behavior within 2 weeks prior to enrollment
排除标准
- •infrequent buying (i.e. less than one time per week) that does not meet proposed criteria for CB
- •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 SCID and SCID-compatible modules for impulse control disorders, 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
- •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
10-30mg, memantine
干预措施: Memantine (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)
时间窗: from study start to study end (8-weeks) and is Investigator rated
The CB-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). Scores ranging from 0 to 10 reflect minimal or mild symptoms; scores from 11 to 20 suggest moderate symptoms; severe symptoms are associated with scores from 21 to 30; and scores greater than 30 reflect extreme buying symptoms
次要结局
未报告次要终点