CTRI/2010/091/000562已完成3 期
Evaluation of efficacy and safety of two antipsychotic agents for the acute treatment of schizophrenia in adults: a randomized, open label, active controlled, multicentric study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
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
- •1. Male or female patients aged between 18 and 65 years.
- •2. Has a primary diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV TR).
- •3. Patient or his/her care taker willing to give their informed consent.
排除标准
- •1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •2. Patients having hypersensitivity to investigational products or any of the excipients of this formulation.
- •3. Patients taking drugs that are known to prolong QTc interval.
- •4. Patients with a history of cardiac arrhythmias.
- •5. Patients having severe renal and hepatic impairment.
- •6. Patients who displayed marked suicidal intent or known suicidal tendencies.
- •7. Alcohol abused patients.
研究者
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