EUCTR2004-000202-49-ES进行中（未招募）1 期
Efficacy of Aripiprazole in Combination with Valproate or Lithium in the Treatment of Mania in Patients with Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy (Revised protocol 1, and amendment 1)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 575
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with Bipolar I Disorder, manic or mixed episode, with or without psychotic features, as defined by DSM-IV-TR and confirmed by the M.I.N.I. who are partially nonresponsive to lithium or valproate monotherapy;
- •- Patients who have a history of at least one previous manic or mixed episode of sufficient severity to require hospitalization, and/or treatment with a mood stabilizer or antipsychotic agent;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients presenting clinically with and/or a history that is consisitent with a DSM-IV -TR diagnosis of :delirium, dementia, amnesia, amnestic or other cognitive disorders, or a psychotic disorder(e.g. schizoprenia or schizoaffective disorder). Also patients with borderline, paranoid, histronis, schizotypal, schzoid or antisocial personality disorder.
研究者
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