An Open Label Pilot Study Evaluating Safety and Efficacy of Divalproex Sodium (Depakote ER) in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Primary Efficacy Measures for this study are: Percent change in MADRS from baseline score to study endpoint; Percent of days heavy drinking from 120 days prescreen to study end point; and Percent of subjects successfully completing outpatient detox.
研究概览
简要总结
The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.
详细描述
Over half of all patients with bipolar disorder have comorbid substance abuse. The most common substance of abuse is alcohol, which is most commonly associated with the depressed phase of the illness. Although there are available treatments for bipolar depression, no studies have been done to evaluate efficacy in bipolar patients with comorbid substance abuse disorders. Given the independent open-label evidence for efficacy and safety of divalproex sodium in alcohol abuse and bipolar depression, divalproex sodium is the most likely candidate for potential success in bipolar depressed patients with comorbid alcohol abuse or dependence. The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •MADRS >= 20 at screen and 18 at baseline
- •YMRS =< 11 at screen and baseline
- •DMS-IV criteria for past manic or hypomanic episode based on the SCID
- •DSM-VI criteria for alcohol dependence or abuse based on the SCID.
- •Alcohol dependence/abuse confirmed by corroboration from family member
- •Negative urine pregnancy test
排除标准
- •Inability to give informed consent
- •Inability to give reliable assessment of alcohol consumption
- •Evidence of alcohol consumption one week prior to baseline
- •Liver function tests greater than 3X upper limit of normal at screen
- •History of active hepatitis or hepatic encephalopathy
- •History of pancreatitis
- •History of adverse reaction to divalproex sodium
- •History of seizure other than directly associated w/prior alcohol withdrawl
- •History of major head trauma with LOC > 10 min. or skull fracture
- •Hisotry of hypertension or neurologic illness
- •If female, not practicing an effective form of birth control
结局指标
主要结局
Primary Efficacy Measures for this study are: Percent change in MADRS from baseline score to study endpoint; Percent of days heavy drinking from 120 days prescreen to study end point; and Percent of subjects successfully completing outpatient detox.
次要结局
- Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16.