NCT00107939已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Licarbazepine 750 ¿ 2000 mg/d as Adjunctive Therapy to an Atypical Antipsychotic in the Treatment of Manic Episodes of Bipolar I Disorder Over 6 Weeks
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 24
- 主要终点
- Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
- •In need of psychiatric treatment
- •Cooperation and willingness to complete all aspects of the study
排除标准
- •Current diagnosis other than bipolar I disorder
- •History of schizophrenia or schizoaffective disorder
- •Drug dependence within 1 month prior to study start or testing positive in a urine drug test
- •Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
- •Any form of psychotherapy within 1 month prior to study start
结局指标
主要结局
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)
次要结局
- Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.
研究者
研究点 (24)
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