A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
研究概览
简要总结
The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive 10 weeks of open-label treatment with memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with PG. We hypothesize that memantine will reduce the severity of gambling symptoms and improve patients' overall functioning. This 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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Pathological Gambling using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
- •Gambling behavior within 2 weeks prior to enrollment;
- •For women, negative results on a urine pregnancy test and stable use of a medically accepted form of contraception.
排除标准
- •Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
- •Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, 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 (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;
- •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 to 30 mg/day memantine. The study consisted of 10 weeks of open-label memantine. All eligible study subjects were started at 10 mg/day for 2 weeks. The dose was increased to 20 mg/day after 2 weeks and then to 30 mg/day after 4 weeks unless remission of PG symptoms was attained at a lower dose.
干预措施: Memantine Hydrochloride (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
时间窗: Baseline to study end point (10 weeks)
The PGYBOCS is a reliable \& valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.
次要结局
未报告次要终点
研究者
Marc Potenza
Professor of Psychiatry, Child Study, and Neurobiology
Yale University