Clozapine and Olanzapine in the Treatment of Violence in Schizophrenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of aggressive incidents
研究概览
简要总结
This was a double-blind randomized study with three treatment arms: clozapine, olanzapine and haloperidol. We compared these three medications in the treatment of aggressive behavior over a 12 week period.
详细描述
Objective
The purpose of our study was the investigation of the effect of atypical antipsychotic agents on interpersonal violence and aggression.
We compared the efficacy of two atypical antipsychotic agents, clozapine and olanzapine with one another and with haloperidol in the treatment of physical assaults and other assaultive behaviors in physically assaultive patients with schizophrenia and schizoaffective disorder.
Method: The subjects were 110 physically assaultive inpatients diagnosed with schizophrenia or schizoaffective disorder.
They were randomly assigned to treatment with clozapine (N=37), olanzapine (N=37) or haloperidol (N=36) in a 12-week, double-blind trial. Incidents of overt aggression were recorded and their severity was scored with the Modified Overt Aggression Scale (MOAS). Psychiatric symptoms were assessed through the Positive and Negative Syndrome Scale (PANSS). We also assessed various side effects and monitored vital signs and drew bloods.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 60 years.
- •Diagnosis of schizophrenia or schizoaffective disorder.
- •Aggression: One episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the Positive and Negative Syndrome Scale (PANSS) Hostility Item.
排除标准
- •Patients who were hospitalized for more than a year
- •Patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication)
- •Patients who had a history of clozapine, olanzapine, or haloperidol intolerance
- •Patients who had medical conditions that would be adversely affected by any of these three medications.
- •Patients who received a depot antipsychotic within 30 days before randomization.
研究组 & 干预措施
clozapine
During the first 6 weeks clozapine was gradually increased to 500 mg/day and then continued. For the next period, it could vary from 200-800 mg/day;
干预措施: Clozapine (Drug)
Olanzapine
During the first 6 weeks olanzapine was increased to 20 mg and remained fixed for until the end of six week. During the last 6 weeks olanzapine could vary from 10 to 30 mg/day
干预措施: Olanzapine (Drug)
Haloperidol
During the first 6 weeks haloperidol was increased to 20 mg and remained fixed for until the end of six week. During the last 6 weeks the dose could vary from 10 to 30 mg/day
干预措施: Haloperidol (Drug)
结局指标
主要结局
Number of aggressive incidents
时间窗: 12 weeks
The Modified Overt Aggression scale (MOAS) was used to record all aggressive incidents. The primary measure was the total score on the MOAS as well as the score on the MOAS physical aggression subscale
次要结局
- Psychiatric Symptoms(12 weeks)
- Side effects of medications(12 weeks)