NCT00418873终止4 期
A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 39
- 主要终点
- Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
研究概览
简要总结
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years, male or female
- •In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to
- •Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4
排除标准
- •Patients with history of seizure or with alcohol or substance abuse in the last 6 months
- •Diabetes, Parkinson's disease or phaeochromocytoma
- •Patients with hypertension and current use of antihypertensive agents
- •Women who are pregnant, lactating or intend to become pregnant during the study period
- •Poor response to two different antipsychotics in full dose and full course or use of clozapine previously
- •Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation
研究组 & 干预措施
1. Zotepine
Experimental
干预措施: Zotepine (Drug)
2. Risperidone
Active Comparator
干预措施: Risperidone (Drug)
结局指标
主要结局
Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
时间窗: 6 Weeks
次要结局
- Change from baseline on the total score of Positive and Negative Syndrome Scale(6 Weeks)
- Change from baseline on Clinical Global Impression (CGI)(6 Weeks)
研究者
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