A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study With an Open-Label Extension to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
- •experiencing a current major depressive episode
排除标准
- •any subject unable to provide informed consent
- •any female subject who is pregnant or breast-feeding
- •any subject judged to be medically inappropriate for study participation
研究组 & 干预措施
40 mg ITI-007 (Lumateperone)
40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
干预措施: ITI-007 (Lumateperone) (Drug)
60 mg ITI-007 (Lumateperone)
60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
干预措施: ITI-007 (Lumateperone) (Drug)
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
时间窗: 6 weeks
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
次要结局
- Time to First Sustained Response in Reduction of MADRS Total Score(6 weeks)