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临床试验/NCT00549718
NCT00549718已完成3 期

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

Sumitomo Pharma America, Inc.48 个研究点 分布在 7 个国家目标入组 489 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Lurasidone HCl (Drug)

Lurasidone 80mg

Experimental

干预措施: Lurasidone HCl (Drug)

Lurasidone 120mg

Experimental

干预措施: Lurasidone HCl (Drug)

Sugar Pill

Placebo Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (48)

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