Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepine in Patients With First-Episode Schizophrenia After One Year Maintenance Treatment Under Further Maintenance Treatment vs. Stepwise Discontinued Drugs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- relapse rate
研究概览
简要总结
Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.
详细描述
In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.
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
- •First-episode in schizophrenia (according ICD-10 F20)
- •Age between 18 and 55
- •Informed consent
- •One year neuroleptic maintenance treatment
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
Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse
干预措施: antipsychotics vs. Lorazepam (Drugs) (Drug)
2
Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse
干预措施: antipsychotics vs. Lorazepam (Drugs) (Drug)
结局指标
主要结局
relapse rate
时间窗: 1 year
次要结局
- quality of life(1 year)
- social and cognitive functioning(1 year)
- psychopathology(1 year)
- side-effects(1 year)
- drop-out(1 year)