A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Time to First Drink (Days)
研究概览
简要总结
To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.
The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adults ages 18-65
- •Meet DSM-IV criteria for current (past 90 days) alcohol dependence
- •Meet DSM-IV criteria for bipolar I or bipolar II disorder
- •Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
- •Must be able to remain free from alcohol for at least 3 days prior to medication initiation
- •Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
- •Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments
排除标准
- •Individuals with a primary psychiatric disorder other than bipolar disorder
- •Individuals with an uncontrolled neurologic condition that could confound the results of the study
- •Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
- •Participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
- •Concomitant use of other psychotropic medications not allowed per the protocol
- •Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
- •Current suicidal or homicidal risk
- •Baseline scores of > 35 on the Montgomery Asberg Depression Rating Scale and/or > 25 on the Young Mania Rating Scale
研究组 & 干预措施
Acamprosate
666 mg p.o. TID
干预措施: Acamprosate (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Drink (Days)
时间窗: 8 weeks
Number of days after randomization until consumption of first alcoholic beverage per self-report.
次要结局
- Percent Days Abstinent(8 weeks)
- Gamma-glutamyltransferase(8 weeks)
- Obsessive Compulsive Drinking Scale Score(8 weeks)
- Young Mania Rating Scale Score(8 weeks)
- Clinical Global Impression Scale Score(8 weeks)
- Percent Heavy Drinking Days(8 weeks)
- Percent Carbohydrate-deficient Transferrin(8 weeks)
- Montgomery Asberg Depression Rating Scale Score(8 weeks)