Efficacy of Valproate Maintenance in Bipolar Alcoholics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in proportion of heavy drinking days
研究概览
简要总结
The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
详细描述
The aim of this study is to test the mood stabilizer, anticonvulsant, sodium valproate in individuals with alcohol dependence and bipolar disorder, in a double-blind, placebo-controlled, and randomized trial of 6 months duration. All subjects are treated with treatment as usual, which include lithium carbonate and individual dual recovery counseling and are randomized to either sodium valproate or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meets the criteria for alcohol dependence with comorbid bipolar disorder.
- •Agreement to participate in outpatient treatment.
- •Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo.
- •Stable living situation.
- •Ability to provide informed consent.
排除标准
- •Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, unipolar major depression, mental retardation, or signs of impaired cognitive functioning.
- •Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination.
- •Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.
- •Persistent elevation of liver function enzymes indicating active liver disease.
- •Pregnancy or not using an acceptable contraceptive method.
- •Inability to read or understand study forms; agree to informed consent.
- •Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder.
- •The presence of either/or cocaine dependence, opioid dependence, and intravenous drug use.
研究组 & 干预措施
sodium valproate
sodium valproate was added on treatment as usual and dose monitored by blood level measurements
干预措施: sodium valproate (Drug)
placebo
Placebo comparator was added on treatment as usual and dose monitored by blood level measurements
干预措施: sodium valproate (Drug)
结局指标
主要结局
Change in proportion of heavy drinking days
时间窗: 6 months
Change from baseline
次要结局
- Changes in depressive and manic symptoms(6 months)