A phase III randomised, double-blind, placebo- and active comparator-controlled clinical trial to study the safety and efficacy of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3)

Dainippon Sumitomo Pharma America Inc. (USA)0 个研究点目标入组 480 人开始时间: 2009年5月26日最近更新: 2019年5月5日

适应症

试验速览

•1. Provide written informed consent and aged between 18 and 75 years of age (both males and females are eligible)
•2. Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia
•3. Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study
•4. Able and agrees to remain off prior antipsychotic medication for the duration of study
•5. Good physical health on the basis of medical history, physical examination, and laboratory screening
•6. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits

•1. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property
•2. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia)
•3. Used investigational compound within 30 days
•4. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months

发起方

Dainippon Sumitomo Pharma America Inc. (USA)