Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

Tracking Information

Start Date  ICMJEOctober 2007
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
Change in total PANSS score from baseline to the end of the double blind phase [ Time Frame: 6 weeks ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00549718 on Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 25, 2007)
CGI-S from baseline to the end of the double-blind treatment [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJELurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Official Title  ICMJEA 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
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJERandomized, Double-Blind, Parallel Assignment
Condition  ICMJESchizophrenia
Intervention  ICMJEDrug: Lurasidone HCl

Recruitment Information

Estimated Enrollment  ICMJE480
Completion Date 
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.
Ages18 Years to 75 Years
Accepts Healthy Volunteers 
Contacts  ICMJE
Contact: Christina Butler, MS,
Location Countries  ICMJEUnited States,   France,   India,   Malaysia,   Romania,   Russian Federation,   Ukraine

Administrative Information

Responsible Party 
Study ID Numbers  ICMJED1050229
Study Sponsor  ICMJEDainippon Sumitomo Pharma America
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Gary Booker, MDUnaffiliated
Principal Investigator:Miranda Chakos, MDState University of New York - Downstate Medical Center
Principal Investigator:Andrew Cutler, MDFlorida Clinical Research Center, LLC
Principal Investigator:Steven DubovskyErie County Medical Center
Principal Investigator:Carlos FigueroaPasadena Research Institute
Principal Investigator:David FlahertySegal Institute for Clinical Research
Principal Investigator:Donald GarciaFuture Search Trials of Neurology
Principal Investigator:Lev GertsikCalifornia Clincal Trials
Principal Investigator:Antony JosephInternational Clinical Research Associates, LLC
Principal Investigator:Gregory KaczenskiK&S Professional Research Services, LLC
Principal Investigator:Mark LermanAlexian Brothers Health System
Principal Investigator:Adam LowyComprehensive NeuroScience, Inc.
Principal Investigator:Raymond ManningCNRI-Los Angles, LLC
Principal Investigator:Morteza MarandiComprehensive NeuroScience, Inc, Cerritos
Principal Investigator:Mark NovitskyCRI Worldwide, LLC @ Kirkbride Center
Principal Investigator:Michael PlopperSharp Mesa Vista Hospital
Principal Investigator:Robert RiesenbergAtlanta Center for Medical Research
Principal Investigator:Kenneth SokolskiClinical Innovations
Principal Investigator:Roger VogelfangerResearch Stategies, Inc
Principal Investigator:David WallingCollaborative Neuroscience Network Inc
Principal Investigator:Kashinath YadalamLake Charles Clinical Trials
Principal Investigator:Robert LitmanCenter for Behavioral Health, LLC
Principal Investigator:Murray RosenthalCalifornia Clinical Trials
Information Provided ByDainippon Sumitomo Pharma America