NCT00868452已完成3 期
A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 71
- 主要终点
- Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
研究概览
简要总结
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is diagnosed with bipolar I disorder, most resent episode depressed
- •Subject must have a lifetime history of at least one bipolar manic or mixed episode
- •Subject must be taking lithium or divalproex at least 28 days prior to screening
排除标准
- •History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
- •Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
- •Imminent risk of suicide or injury to self, others, or property
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo + (lithium or divalproex) (Drug)
Lurasidone
Experimental
干预措施: lurasidone + (lithium or divalproex) (Drug)
结局指标
主要结局
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
时间窗: Baseline, Week 6
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
次要结局
- Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)(Baseline Week 6)
- Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score(Baselin Week 6)
研究者
研究点 (71)
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