Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol IM Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- the change of PANSS-EC scores
研究概览
简要总结
This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study.
After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.
详细描述
Acute psychotic agitation is a common problem in many patients with schizophrenia that includes agitation, aggression, excitement and violence. An investigation showed that about 26% psychotic patients were brought to the psychiatric emergency room because of the psychotic agitation symptoms. The primary objective is to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia and schizophrenic-affective disorder.
The secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute 6 weeks treatment from IM injection to oral; (2) to compare the safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 to 45 years
- •DSM-IV diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
- •A score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the PNASS
- •The total scores ≥60 on the PANSS
排除标准
- •Women who are pregnant or breast feeding, or who plan to become pregnant during the study
- •The psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
- •Clinical laboratory values indicating serious medical illness
- •Known hypersensitivity to any of the study medications
- •Treatment with a depot antipsychotic with 1 cycle of screening
- •Using of disallowed medication
研究组 & 干预措施
oral group
risperidone oral solution combination clonazepam oral
干预措施: risperidone oral solution (Drug)
IM group
haloperidol IM injection
干预措施: haloperidol (Drug)
结局指标
主要结局
the change of PANSS-EC scores
时间窗: 5 days
次要结局
- response rate based on the PANSS(47 days)