NCT01284517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 in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 75
- 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
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Provide written informed consent and is 18 to 75 years of age inclusive.
- •Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
- •Has a lifetime history of at least one bipolar manic or mixed manic episode.
- •Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
- •Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
- •Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
- •Good physical health on the basis of medical history, physical examination, and laboratory screening.
排除标准
- •Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- •Any chronic organic disease of the CNS (other than Bipolar I Disorder).
- •Hospitalization for a manic or mixed episode within the past two months.
- •Used investigational compound within past 6 months.
- •Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
研究组 & 干预措施
Lurasidone 20-120 mg flexible dose
Experimental
干预措施: Lurasidone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (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 to 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 to week 6)
- Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score(Baseline to week 6)
研究者
研究点 (75)
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