A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 901
- 试验地点
- 108
- 主要终点
- Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
研究概览
简要总结
- To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
- •Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
- •OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).
排除标准
- •Four or more episodes of a mood disturbance within the 12 months before Visit 1;
- •Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.
研究组 & 干预措施
Double-Blind Cariprazine 3.0 mg/day
Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.
干预措施: Cariprazine (Drug)
Double-Blind Cariprazine 1.5 mg/day
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
干预措施: Cariprazine (Drug)
Double-Blind Placebo
Participants randomized to receive placebo QD for up to 39 weeks.
干预措施: Placebo (Drug)
Open Label Treatment
Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
干预措施: Cariprazine (Drug)
结局指标
主要结局
Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
时间窗: From Week 16 to Week 55
Relapse was defined as the occurrence of any 1 of the following: * Young Mania Rating Score (YMRS) total score ≥ 17 (range 0-60; higher score indicates a worse outcome); * Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20 (range 0-60; higher score indicates more depressive symptoms); * Clinical Global Impression-Improvement scale (CGI-S) ≥ 4 (range from 1 \[normal, not at all ill\] to 7 \[extremely ill\]); * Initiation of additional psychiatric medication; * Psychiatric hospitalization; * Exacerbation of illness as judged by clinical impression of the Investigator. Time to first relapse (days) was calculated as the date of the first relapse - the date of randomization + 1. Participants who did not meet the relapse criteria were considered censored at the time of completion or discontinuation from the Double-Blind Treatment Period (DBTP) of the study. Percentiles (95% Confidence Intervals \[CI\]) are based on Kaplan-Meier estimates.
次要结局
未报告次要终点