NCT00277212已完成4 期
A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode
Otsuka Pharmaceutical Development & Commercialization, Inc.129 个研究点 分布在 1 个国家目标入组 1,169 人开始时间: 2005年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,169
- 试验地点
- 129
- 主要终点
- Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
研究概览
简要总结
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic
排除标准
- •First manic episode
- •Current manic or mixed episode with > 2 years duration
- •Treated with aripiprazole within the past 3 months
- •Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
研究组 & 干预措施
A2
Placebo Comparator
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo
干预措施: Lamotrigine + Placebo (Drug)
A1
Experimental
Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole
干预措施: Lamotrigine + Aripiprazole (Drug)
结局指标
主要结局
Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
时间窗: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
次要结局
- Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs(Throughout Phase 2 (up to 52 weeks))
- Adjusted Mean Change From Baseline in Body Weight, Phase 2(Baseline, Week 52)
- Number of Participants Showing Clinically Relevant Weight Loss by Study Week(Weeks 12, 24, 36, 52)
- Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2(Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)(Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)(Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52)
- Adjusted Mean Change From Baseline in BMI by Study Week(Baseline, Weeks 12, 24, 36, 52)
- Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment(Throughout the study, up to Week 52)
- Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment(Up to 52 Weeks)
- Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)(Throughout Phase 2 of the study, up to Week 52)
- Summary of Concomitant Medications, Phase 1(Phase 1 (9 to 24 Week Single-blind Stabilization Phase))
- Summary of Concomitant Medications, Phase 2(Phase 2 (52 Week Double-blind Relapse Assessment Phase))
- Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score(Baseline, Weeks 8, 24, 36, 52)
- Number of Participants Showing Clinically Relevant Weight Gain by Study Week(Weeks 12, 24, 36, 52)
- Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score(Baseline, Weeks 8, 24, 36, 52)
- Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,(Baseline, Weeks 8, 24, 36, 52)
研究者
研究点 (129)
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