A Multiple-Center, Randomized, Double-Blind Study of Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The severity of psychosis
研究概览
简要总结
Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both paliperidone and risperidone are second generation antipsychotics，but have same pharmacological effects of antipsychotic treatment and paliperidone may have more efficacy and safty.This study was designed to examine the acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with MAP.
详细描述
Methods:A Multiple-Center, Randomized, Double-Blind.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
- •Must sign a Information consent form.
- •Required to provide detailed address and phone number
排除标准
- •Serious organic disease.
- •Suicide ideation or hurt others.
- •Taking antipsychotic within two weeks before.
- •drug allergy to Risperidone or paliperidone.
- •pregnancy and breastfeeding women.
研究组 & 干预措施
paliperidone
paliperidone arm,6mg/pill,6-12mg/day,non-forced titration method.last2-4weeks.
干预措施: paliperidone (Drug)
.Risperidone
Risperidone arm and placebo tables,1mg/pill,2mg-6mg/day,non-forced titration method.last2-4weeks
干预措施: Risperidone (Drug)
结局指标
主要结局
The severity of psychosis
时间窗: up to 4 weeks. participants will be followed for the duration of hospital stay
Positive and Negative Syndrome Scale
次要结局
- Clinical general status(up to 4 weeks. participants will be followed for the duration of hospital stay)
研究者
Wei Hao
The Second Xiangya Hospital of Cental South University
Central South University