A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 26
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
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 (Participant, Investigator)
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, 18-65 years old
- •Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
- •A verified previous manic, hypomanic, or mixed episode
- •Score of 20 or higher on the HAMD-17
- •Score of 2 or higher on Item 1 of the HAMD
排除标准
- •Score greater than 12 on the Young Mania Rating Scale
- •Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
- •Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)
研究组 & 干预措施
1
0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.
干预措施: cariprazine (Drug)
2
1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
干预措施: cariprazine (Drug)
3
Matching placebo capsules, oral administration, once daily dosing.
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline to Week 8
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.
次要结局
- Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )(Baseline to Week 8)