A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Number of participants experiencing clinical and laboratory adverse events (AEs)
研究概览
简要总结
Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Asenapine 5 mg
Participants who were randomized to asenapine 5 mg twice per day (BID) during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension study. Participant who were randomized to placebo during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension trial.
干预措施: asenapine (Drug)
Asenapine 10 mg
Participants who were randomized to asenapine 10 mg BID during the P05691 study will be assigned to receive asenapine 10 mg BID on this extension study.
干预措施: asenapine (Drug)
结局指标
主要结局
Number of participants experiencing clinical and laboratory adverse events (AEs)
时间窗: Baseline up to 212 days
次要结局
未报告次要终点