NCT04819776已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iloperidone for 4 Weeks in the Treatment of Patients With Acute Manic Episodes Associated With Bipolar I Disorder
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
- 417
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score
研究概览
简要总结
The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating 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
- Quadruple (Participant, Care Provider, 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
- •Male or female patients 18 to 65 years of age (inclusive)
- •Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
- •Voluntary hospitalization for current manic episode
排除标准
- •Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
- •Patients who are experiencing a first manic episode or meeting criteria for rapid cycling
研究组 & 干预措施
Iloperidone
Experimental
干预措施: Iloperidone (Drug)
Placebo
Placebo Comparator
干预措施: Iloperidone Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score
时间窗: Week 4
The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
次要结局
未报告次要终点
研究者
研究点 (1)
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