CTRI/2010/091/000296已完成3 期
Evaluation of efficacy and safety of opipramol versus alprazolam in the treatment of generalized anxiety disorder: 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. Patient has a primary diagnosis of generalized anxiety disorder according to Diagnostic and Statistical Manual of Mental disorder IV Text Revision (DSM-IV TR) (See Appendix-I).
- •3. Patients having total score of minimum of 17 on Hamilton Rating Scale of Anxiety.
- •4. Patient 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 with known hypersensitivity to Opipramol (G3040) or Alprazolam (U31889) or any of the excipients of this formulation.
- •3. Patients taking MAO inhibitors.
- •4. Patients with acute narrow angle glaucoma.
- •5. Patients with prostate hypertrophy.
- •6. Alcohol abused patients.
- •7. Patients having severe renal and hepatic impairment.
- •8. Patients who displayed marked suicidal intent or known suicidal tendencies.
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