NCT00107926已完成3 期
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar 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
- 343
- 试验地点
- 4
- 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 treatment with either lithium or valproate, which 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
研究组 & 干预措施
licarbazepine
Experimental
干预措施: Licarbazepine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
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
- Major improvement in anxiety and depression from baseline to endpoint (week 6)
研究者
研究点 (4)
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