CTRI/2011/091/000140已完成3 期
A randomized, open label, comparative, multicentric, phase 3 clinical study to assess the efficacy and safety of Blonanserin tablets in comparison with Haloperidol tablets in patients suffering from schizophrenia - None
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.Patients between 18-65 years of age.
- •2.Patients with diagnosis of schizophrenia.
- •3.Informed consent.
排除标准
- •1.Pregnancy and/or lactation.
- •2.Patients with suicidal tendencies.
- •3.Patients with relevant CNS disorders or history of such disorders.
- •4.Patients with a history of neuroleptic malignant syndrome (NMS).
- •5.Patients with uncontrolled diabetes or significant cardiovascular diseases.
- •6.Patients with angle-closure glaucoma, benign prostatic hyperplasia, urinary retention or paralytic ileus.
- •7.Patients with significant renal or hepatic impairment, acute infections, leucopenia, hyperthyroidism or SIADH.
- •8.Impoverished patients.
- •9.Patients with an organic psychiatric disorder.
- •10.History of hypersensitivity to study medication.
- •11.Patients requiring concomitant treatment which is not permissible.
- •12.Patients with any other serious concurrent illness or malignancy.
- •13.Patients with continuing history of alcohol and/or drug abuse.
- •14.Participation in another clinical trial in the past 3 months.
研究者
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