GiSAS Trial: Aripiprazole, Olanzapine, and Haloperidol in the Long Term Treatment of Schizophrenia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The measure for tolerability is the onset of metabolic syndrome as defined by meeting at least 3 of the following criteria: (1) abdominal obesity, (2) high triglycerides, (3) high HDL, (4) high blood pressure and (5) hyperglycaemia.
研究概览
简要总结
The GiSAS study is a multi-centre randomized clinical trial that will involve about 80 italian community psychiatric services in Italy and will recruit 800 patients affected by schizophrenia.
In a sample of schizophrenic outpatients, it is hypothesized that there are significant differences in the overall tolerability and effectiveness of aripiprazole, olanzapine and haloperidol at 12 months.
It is a pragmatic trial. Thus, participants are selected to represent a broad range of "real-world" patients, all treatment medications are non-blinded and after randomization, the assigned drugs will be prescribed according to usual care practice.
The measure for effectiveness is retention of patients on the assigned treatment. The measure for tolerability is the onset of metabolic syndrome.
详细描述
Specific aim.
The GiSAS study is a randomized controlled superiority trial that aims to evaluate the tolerability and effectiveness of aripiprazole, olanzapine and haloperidol in outpatients with schizophrenia over a 12-month period.
Inclusion criteria.
- Age≥18.
- Patients entering the study must have a condition appropriate for changing the antipsychotic treatment or starting a new one.
Exclusion criteria.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women, 18 years of age and over, who meet DSM-IV criteria for schizophrenia, based upon the Mini International Neuropsychiatric Interview;
- •patients entering the study must, according to their own judgment in consultation with their physician, have a condition appropriate for (a) starting treatment with an oral antipsychotic medication or (b) changing antipsychotic treatment.
排除标准
- •diagnosis of metabolic syndrome, defined as the fulfilling of at least 3 of the diagnostic criteria for the metabolic syndrome derived from Adult Treatment Protocol III (ATP III);
- •diagnosis of diabetes mellitus type II;
- •presence of an organic condition clearly contraindicating treatment with one of the studied drugs, e.g., pregnancy or breast-feeding;
- •one of the studied treatments is positively known to be ineffective or not tolerable and consequently contraindicated;
- •the patient has never been exposed to antipsychotic drugs;
- •according to clinician's opinion, it is unlikely that the patient can be followed for the whole duration of the study (1 year).
研究组 & 干预措施
Aripiprazole
Aripiprazole (N05AX12)
干预措施: Aripiprazole (Drug)
Olanzapine
Olanzapine (N05AH03)
干预措施: Olanzapine (Drug)
Haloperidol
Haloperidol (N05AD01)
干预措施: Haloperidol (Drug)
结局指标
主要结局
The measure for tolerability is the onset of metabolic syndrome as defined by meeting at least 3 of the following criteria: (1) abdominal obesity, (2) high triglycerides, (3) high HDL, (4) high blood pressure and (5) hyperglycaemia.
时间窗: 12 months
次要结局
- Global functioning and symptomatology (GAF)(12 months.)
- Neuroleptic side effects' self-rating (LUNSERS)(12 months)
- The primary measure for effectiveness is retention of patients on the assigned treatment at 12 months. Switching to another antipsychotic, adding a second antipsychotic or stopping antipsychotic treatment will be considered as drug discontinuation.(12 months)
- Time to discontinuation due to efficacy(12 months.)
- Time to discontinuation due to side effects(12 months)
- Worsening of metabolic profile(12 months)