A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Number of Participants Who Experienced an Adverse Event
研究概览
简要总结
The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial
排除标准
- •Have an unstable medical condition or clinically significant laboratory abnormality.
- •Have a primary diagnosis other than bipolar I disorder.
研究组 & 干预措施
Asenapine
Asenapine
干预措施: Asenapine (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event
时间窗: up to 52 weeks
Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).
Number of Participants Who Discontinued Because of an Adverse Event
时间窗: 40 weeks
Participants who discontinued study medication due to adverse events.
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
时间窗: Baseline and 52 Weeks
The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
时间窗: Baseline and 52 Weeks
The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.
次要结局
未报告次要终点