A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three 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
- 489
- 试验地点
- 48
- 主要终点
- Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
研究概览
简要总结
Lurasidone HCl is a compound being 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
- 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
- •To be eligible to enter the study, each patient must comply with the following inclusion criteria:
- •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
Lurasidone 40mg
干预措施: Lurasidone HCl (Drug)
Lurasidone 80mg
干预措施: Lurasidone HCl (Drug)
Lurasidone 120mg
干预措施: Lurasidone HCl (Drug)
Sugar Pill
干预措施: Lurasidone HCl (Drug)
结局指标
主要结局
Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
时间窗: 6 weeks
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
次要结局
- CGI-S From Baseline to the End of the Double-blind Treatment(6 weeks)