Ecopipam Treatment of Pathological Gambling
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
研究概览
简要总结
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.
详细描述
The purpose of this study is to determine if ecopipam is able to stop urges to gamble in patients diagnosed with Pathological Gambling. Nerves communicate with each other by releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that selectively blocks one family of dopamine receptors. Some scientists believe that the urge to gamble is related to having too much dopamine in the brain. By blocking the receptors that dopamine uses, ecopipam may be able to relieve the urge to gamble.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be diagnosed with Pathological Gambling according to DSMIV criteria
- •Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening
- •Subject must have gambling urges of at least moderate intensity
排除标准
- •Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam
- •Subjects with major depressive episode within the last 2 years
- •Subjects with a history of attempted suicide
- •Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide
- •Subjects with a history of epilepsy or seizures
- •Subjects with a myocardial infarction (heart attack) with in the last 6 months
- •Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any psychotic disorder
- •Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence (with the exception of nicotine)
研究组 & 干预措施
Ecopipam
Ecopipam is a selective antagonist of one the classes of dopamine receptor.
干预措施: Ecopipam (Drug)
Placebo
Placebo given first week of the study.
干预措施: Ecopipam (Drug)
结局指标
主要结局
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
时间窗: Baseline and 6 weeks
This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.
次要结局
- Statistically Significant Changes in the Gambling Symptom Assessment Scale(6 weeks)
- Effects on the Clinical Global Impression(6 weeks)
- Type, Frequency and Severity of Side Effects(6 weeks)