A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 52
- 主要终点
- Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
研究概览
简要总结
Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.
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, Care Provider, Investigator)
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
- •Provide written informed consent and aged between 18 and 75 years of age.
- •Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
- •Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- •Able and agrees to remain off prior antipsychotic medication for the duration of study.
- •Good physical health on the basis of medical history, physical examination, and laboratory screening.
- •Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
排除标准
- •Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
- •Any chronic organic disease of the CNS (other than schizophrenia).
- •Used investigational compound within 30 days.
- •Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
研究组 & 干预措施
Lurasdione 40mg tablets
干预措施: Lurasidone 40 mg tablets (Drug)
120mg
干预措施: Lurasidone (Drug)
15mg Olz
干预措施: Olanzapine (Drug)
Sugar pill
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
时间窗: Baseline and 6 weeks
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
次要结局
- CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.(6 weeks)