NCT00330486已完成1 期
The Use of Acamprosate in Alcohol-Dependent Individuals With Bipolar Disorder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Alcohol use as determined by the time-line follow-back instrument
研究概览
简要总结
The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder. All subjects in the study must be currently stabilized on mood-stabilizing medication. Half of the subjects will receive acamprosate in addition to their mood-stabilizing medication; control subjects will be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as mood stability will be obtained weekly throughout the active phase of the study.
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
- 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
- •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, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past month
- •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 creatine 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
结局指标
主要结局
Alcohol use as determined by the time-line follow-back instrument
次要结局
- Mood stability as determined by the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale
研究者
研究点 (2)
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