CTRI/2013/09/003950已完成4 期
A PROSPECTIVE RANDOMIZED, OPEN-LABEL, COMPARATIVE TRIAL ON EFFICACY AND SAFETY OF ASENAPINE Vs OLANZAPINE IN MANIC EPISODE OF BIPOLAR-1 DISORDER PATIENTS - RAO
nil0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •OPD patients
- •Patient free of psychotropic drugs for at least 1 month
- •Age > 18 or < 55 yrs
- •Legitimate consent
- •Those who meet DSM-IV-TR criteria for acute mania in Bipolar1 disorder (American Psychiatric Association, 2000).
排除标准
- •Pregnancy, lactation
- •H/o epilepsy
- •Presence of uncontrolled, unstable, clinically significant medical condition
- •Narrow angle glaucoma
- •Primary psychiatric disorder other than bipolar
- •History of substance dependence
- •History of rapid cycling ((American Psychiatric Association, 2000)
- •Judged by the clinical investigator - inability to reduce intake of lorazepam to a maximum of 4 mg per day
- •Intolerant or allergic to the drug
研究者
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