A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 68
- 主要终点
- Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events
研究概览
简要总结
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296
详细描述
To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.
Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).
Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has agreed to participate by providing written informed consent.
- •Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
- •Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
- •Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
- •Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
排除标准
- •Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
- •Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).
研究组 & 干预措施
Lurasidone
Lurasidone 20, 40, 60,80 mg flexible dose
干预措施: Lurasidone (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events
时间窗: 12 weeks
Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation
次要结局
- Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)(Baseline, 12 weeks (LOCF))
- Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score(baseline, 12 weeks (LOCF))
- Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score(baseline, 12 weeks (LOCF))
- Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)(baseline ,Week 12 (LOCF))
- Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)(baseline, week 12 (LOCF))
- Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score(baseline, week 12 (LOCF))
- Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale(baseline, week 12 (LOCF))
- Change From Baseline to Week 12 (LOCF) in the SDS Total Score(baseline, week 12 (LOCF))