NCT05803642尚未招募3 期
A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 318
- 主要终点
- Change from baseline to 2 hours post-first IM injection on the PANSS-EC
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 and female patients between the ages of 18 to 65 years, inclusive.
- •Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder.
- •Patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the PANSS-EC and at least one individual item score≥ 4 immediately before randomization.
排除标准
- •Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse.
- •Patients who have had previous suicidal behavior or currently at serious risk of suicide.
- •Patients with glaucoma or at risk of angle-closure glaucoma.
- •Patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, Parkinson's disease, Parkinson's syndrome, and dementia.
- •Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization.
- •Treatment with psychostimulants or reserpine within one week before randomization.
- •Patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval.
- •Treatment with clozapine within 4 weeks before screening.
- •Patients with serious or unstable medical illnesses.
- •Female patients who have a positive pregnancy test at screening or are breastfeeding.
- •Patients who have participated in other clinical trials within 3 months before randomization.
研究组 & 干预措施
Olanzapine
Experimental
干预措施: Olanzapine (Drug)
Haloperidol
Active Comparator
干预措施: Haloperidol (Drug)
结局指标
主要结局
Change from baseline to 2 hours post-first IM injection on the PANSS-EC
时间窗: 2 hours
The PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
次要结局
- Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score(2 hours post-first IM injection)
- Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period(24 hours)
研究者
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