One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- relapse rate
研究概览
简要总结
Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.
详细描述
The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
- •Age between 18 and 55
- •Informed consent
排除标准
- •Residence outside of the catchment area
- •Legal reasons
- •Insufficient knowledge of the German language
- •Substance abuse or addiction
- •Pregnancy
- •Serious physical illness
- •Organic brain disease
- •Contraindication to neuroleptic treatment
研究组 & 干预措施
1
Maintenance antipsychotic treatment with risperidone
干预措施: Haloperidol, Risperidone (drug) (Drug)
2
Maintenance antipsychotic treatment with haloperidol in low-dose
干预措施: Haloperidol, Risperidone (drug) (Drug)
结局指标
主要结局
relapse rate
时间窗: 1 year
次要结局
- course in psychopathology(1 year)
- social and cognitive functioning(1 year)
- side-effects(1 year)
- drop-out(1 year)
- quality of life(1 year)