NCT00485901已完成3 期
A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection
研究概览
简要总结
The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, between the ages of 18 and 65
- •Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
- •Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
- •Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
- •Patient must be hospitalized during the study
排除标准
- •Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
- •Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
- •Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
- •Documented history of allergic reaction to study medication(s)
- •Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
结局指标
主要结局
Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection
次要结局
- Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study
- Assess the efficacy of IM olanzapine compared with IM haloperidol from baseline to 15 min, 30 min, 60 min and 120 minutes post-first IM injection
- Compare the response rates and time to response during the 2 hours post-first IM injection.
研究者
研究点 (1)
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