NCT00395915Unknown4 期
Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia. An Independent, Pragmatic, Multicentre, Parallel-Group, Superiority Trial.
Universita di Verona2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Withdrawal from allocated treatment within 3 months.
研究概览
简要总结
The principal clinical question to be answered by CHAT (Clozapine Haloperidol Aripiprazole Trial) is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared to combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time.
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
- None
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
- •Current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by DSM-IV criteria).
- •Treatment with clozapine for at least six months at a stable dose of 400 mg or more per day, unless the size of the dose was limited by side-effects.
- •Unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis)
- •Age 18 and above.
- •Agreement between investigator and patient to enter the study.
- •The patient is normally resident in Italy.
- •It is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol.
- •Uncertainty about which trial treatment would be best for the participant.
- •No medical disorder or condition contraindicates either of the investigational drugs.
- •Agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
排除标准
- 未提供
结局指标
主要结局
Withdrawal from allocated treatment within 3 months.
次要结局
- Concurrent use of adjunctive medication within 3 and 12 months.
- Withdrawal from allocated treatment within 12 months of follow-up.
- Time to withdrawal from allocated treatment.
- Severity of illness, measured at month 3 and 12.
- Withdrawal from study treatment, due to adverse reactions, within 3 and 12 months.
- Concurrent use of antiparkinson medication within 3 and 12 months.
- Adverse events within 3 and 12 months.
- Biological parameters, measured at month 3 and 12.
- Subjective tolerability of antipsychotic drugs, measured at month 3 and 12.
- Deliberate self-harm within 3 and 12 months.
- Metabolic syndrome within 3 and 12 months.
研究者
研究点 (2)
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