A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 35
- 主要终点
- Change From Baseline in the YMRS Total Score at Week 16
研究概览
简要总结
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided informed consent prior to any study specific procedures.
- •Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
- •Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
- •Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).
排除标准
- •Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.
研究组 & 干预措施
Cariprazine 3-12 mg/day for 16 weeks
Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
干预措施: Cariprazine (Drug)
结局指标
主要结局
Change From Baseline in the YMRS Total Score at Week 16
时间窗: Baseline to Week 16
The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11 items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement.
次要结局
- Change From Baseline in the MADRS Total Score at Week 16(Baseline to Week 16)