NCT00316238已完成2 期
A Double-Blind Dose-Response Study Comparing Rapid Acting Intramuscular Olanzapine and Intramuscular Placebo in Agitated Patients With Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 16
- 主要终点
- To evaluate dose-response relationship and to confirm the efficacy of IM olanzapine by sequentially comparing each of IM olanzapine groups and IM placebo group with respect to the changes from baseline to 2 hours post first IM injection of agitation.
研究概览
简要总结
To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have schizophrenia that meets disease diagnostic criteria in DSM-IV-TR
- •Patients must be inpatients during the study
- •Patients must have a minimum total score of no less than 14 on the five items of the PANSS-EC and at least one individual item score of no less than 4 using the 1-7 scoring system prior to the first injection of study drug
排除标准
- •Patients who have a known history of diabetes mellitus.
- •Patients who have received treatment with antipsychotics or other prohibited concomitant medicines within 2 hours prior to the first IM study drug administration
- •Patients who have had treatment with benzodiazepines within 4 hours prior to first IM study drug administration.
结局指标
主要结局
To evaluate dose-response relationship and to confirm the efficacy of IM olanzapine by sequentially comparing each of IM olanzapine groups and IM placebo group with respect to the changes from baseline to 2 hours post first IM injection of agitation.
次要结局
- To determine if the efficacy of IM olanzapine is greater than IM placebo by evaluating sequentially comparing changes at 30 min, 60 min, 90 min post first IM injection of agitation, as measured by the PANSS-EC in schizophrenia patients.
- To determine if the efficacy of IM olanzapine groups are greater than the IM placebo by evaluating sequentially changes from baseline to 2 hours post first IM injection in the rate of responder, CGI-I, and ACES.
- To examine whether a dose-response relationship exists for IM olanzapine in higher agitation, by using mean changes of PANSS-EC total score from baseline to 2 hours post first IM injection as measured by PANSS-EC (Score total no less than 20).
- To compare the efficacy of IM olanzapine(2.5, 5, 7.5, or 10 mg) to IM placebo by evaluating sequentially changes from baseline to 24 hours post first IM injection in the PANSS-EC, CGI-S, Clinical Global Impression-Improvement of Illness (CGI-), and ACES.
- To compare efficacy of IM olanzapine(2.5, 5, 7.5, or 10 mg)to IM placebo in the frequency of patients who need second injection and time to second injection.
- To compare the safety of IM olanzapine groups to IM placebo group over a 24 hours period in terms of ACES, TEAE, changes in laboratory values, pulse, blood pressure, ECG, DIEPSS.
研究者
研究点 (16)
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