Depakote ER Therapy for Mania Comorbid With Substance Abuse
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB.
研究概览
简要总结
The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.
详细描述
This study will be performed in male and female subjects with a diagnosis of bipolar disorder in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This population is selected so the efficacy of Depakote ER in this population can be tested.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.
- •Comorbid diagnoses of anxiety and/or personality disorders are permitted.
- •Ability to provide signed informed consent.
- •Stable general medical health.
- •Ability to attend outpatient research clinic.
排除标准
- •Dangerous to self or others.
- •Pregnancy, inability or unwillingness to use approved methods of birth control.
- •Inability or unwillingness to provide signed informed consent.
- •Diagnosis of schizophrenia, major depressive disorder.
- •Inability to attend outpatient research clinic.
- •Medical conditions, which would preclude use of Depakote.
- •Need for ongoing treatment with medication other than Depakote ER, such as antipsychotic medication.
- •Medical instability defined as likelihood of needing to change prescription medication during the course of the study.
结局指标
主要结局
The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB.
时间窗: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months
次要结局
- The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).(Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months, for a total study duration of 6 months)