A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 497
- 试验地点
- 66
- 主要终点
- Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
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 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) manic or mixed type with or without psychotic symptoms
- •Voluntarily hospitalized for current manic episode
- •Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
排除标准
- •Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
研究组 & 干预措施
Cariprazine (3-6 mg/day)
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
干预措施: Cariprazine (Drug)
Cariprazine (6-12 mg/day)
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
干预措施: Cariprazine (Drug)
Placebo
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
时间窗: Baseline, Week 3
The YMRS is an 11-item scale that assesses manic symptoms based on the participant'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 the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
次要结局
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3(Baseline, Week 3)