NCT00245973已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder
Wyeth is now a wholly owned subsidiary of Pfizer40 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 40
- 主要终点
- Secondary measurement scales will be used:
研究概览
简要总结
The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 to 65 years of age, inclusive.
- •Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.
排除标准
- •This is a follow on study to protocol 3168A2-
- •Only subjects who have participated in the previous study are eligible.
结局指标
主要结局
Secondary measurement scales will be used:
Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
次要结局
- Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
- Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
- Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
- Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
- Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8
研究者
研究点 (40)
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