NCT00114686已完成3 期
A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 350
- 试验地点
- 38
- 主要终点
- Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
研究概览
简要总结
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence
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
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for Bipolar I Disorder with Alcohol dependence
- •Outpatient Status
- •Recent history of heavy drinking
排除标准
- •Unstable medical illness
- •Recent antipsychotic use
- •Poorly controlled Diabetes Mellitus or Diabetes related illness
结局指标
主要结局
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
次要结局
- Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
- Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score
研究者
研究点 (38)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive DisorderMajor Depressive DisorderNCT00388973AstraZeneca338
已完成
3 期
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety DisorderAnxiety DisordersNCT00389064AstraZeneca450
已完成
3 期
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With SchizophreniaSchizophreniaNCT00090324AstraZeneca249
已完成
3 期
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I ManiaBipolar DisorderNCT00090311AstraZeneca220
已完成
3 期
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety DisorderGeneralized Anxiety DisorderNCT00329264AstraZeneca876