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Clinical Trials/ISRCTN64695913
ISRCTN64695913
Completed
Phase 3

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 sites480 target enrollmentMay 26, 2009
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ConditionsSchizophreniaMental and Behavioural Disorders

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Dainippon Sumitomo Pharma America Inc. (USA)
Enrollment
480
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

  1. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/24035633 (added 10/04/2019) 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26117157 (added 10/04/2019)
Registry
who.int
Start Date
May 26, 2009
End Date
December 12, 2009
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dainippon Sumitomo Pharma America Inc. (USA)

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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