NCT00954603终止3 期
Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- decrease in delirium rating scale and clinical global improvement
研究概览
简要总结
The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.
详细描述
A delirious state often founds in general hospitals and remains a significant cause of death. Existing methods of treatment includes identification and elimination of factors contributing to the delirium in addition to pharmacological and nonpharmacological treatment interventions (Trzepacz et al., 1999). Antipsychotics can play an important role in the management of the symptoms of delirium.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 -75 years
- •Was admitted in Maharaj Nakhon Chiang Mai hospital
- •Was diagnosed by the diagnostic criteria for DSM-IV-TR delirium due to a general medical condition or delirium due to multiple etiologies
- •Delirious state (delirium) of the patients was confirmed by using name-assess confusion assessment method (CAM) and assessment of severity with delirium rating scale-revised-98 (DRS-R-98)
- •Have a written consent from the legal representatives
排除标准
- •Was diagnosed substance withdrawal delirium
- •Having a history drug allergy either from quetiapine or haloperidol
- •Female patients who are pregnant or breastfeeding
- •No written consent from the legal representatives
- •Received other anti-psychotic drug before attend the study
- •Being ill with renal or hepatic failure
研究组 & 干预措施
quetiapine
Experimental
atypical antipsychotic drug
干预措施: quetiapine (Drug)
haloperidol
Active Comparator
typical antipsychotic drug
干预措施: haloperidol (Drug)
结局指标
主要结局
decrease in delirium rating scale and clinical global improvement
时间窗: 7 days
次要结局
- compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.(7 days)
研究者
研究点 (1)
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