NCT00314821已完成4 期
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
研究概览
简要总结
To demonstrate efficacy and safety of Requip in in treating bipolar depression.
详细描述
This study is 8 weeks long, with an optional additional 8 weeks. The study is placebo-controlled and patients are randomized to receive either ropinerol or placebo. Changes in depression, anxiety and overall psychiatric symptoms will be monitored during participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV criteria for bipolar disorder
- •Current MADRS score > 16
- •Current MRS-SADS score < 10
- •Prior to participation in this study, each subject must sign an informed consent.
- •All patients will be required to also take at least one other mood-stabilizing agent, defined as a standard agent (lithium, valproate, carbamazepine) or a novel anticonvulsant agent (oxcarbazepine, gabapentin, topiramate). If patients are not taking any of these agents on study initiation, they will be required to start one of these agents at study initiation. Study inclusion criteria must be met after at least 2 weeks of treatment with one of these mood-stabilizing agents.
排除标准
- •Any serious acute medical illness
- •Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale
结局指标
主要结局
Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
次要结局
- The secondary outcomes will include predictors of response, such as insight into illness, comorbid anxiety symptoms, prior course of illness, previous treatment history with antidepressants, and other relevant clinical and demographic features.
研究者
研究点 (4)
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