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A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia

This study has been completed.

Sponsored by: Sumitomo Pharmaceuticals America
Information provided by: Sumitomo Pharmaceuticals America
ClinicalTrials.gov Identifier: NCT00088634
  Purpose

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia


Condition Intervention Phase
Schizophrenia
Drug: SM-13496
Phase II

MedlinePlus related topics:   Schizophrenia   

ChemIDplus related topics:   SM-13496    Lurasidone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Double-Blind Fixed-Dose Study Antipsychotic and Placebo in the Treatment of Schizophrenia

Further study details as provided by Sumitomo Pharmaceuticals America:

Estimated Enrollment:   160
Study Start Date:   May 2004
Estimated Study Completion Date:   December 2004

Detailed Description:

Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

  Eligibility
Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
  • The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
  • If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception

Exclusion Criteria:

  • The patient has used an investigational drug within the past 30 days
  • The patient has participated in a previous study of this compound
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088634

Locations
United States, Alabama
Birmingham Psychiatry Pharmaceutical    
      Birmingham, Alabama, United States, 35209
United States, Arkansas
Summit Research Group    
      Little Rock, Arkansas, United States, 72211
United States, California
Comprehensive NeuroScience    
      Cerritos, California, United States, 90703
Collaborative Neuro Science Network, Inc.    
      Garden Grove, California, United States, 92845
Pacific Clinical Research    
      Upland, California, United States, 91786
United States, District of Columbia
Comprehensive NeuroScience, Inc    
      Washington, District of Columbia, United States, 20016
United States, Florida
University of South Florida, Department of Psychiatry and Behavioral Medicine    
      Tampa, Florida, United States, 33613
Segal Institute for Clinical Research    
      North Miami, Florida, United States, 33161
United States, Illinois
Comprehensive Neuroscience, Inc.    
      Hoffman Estates, Illinois, United States, 60194
United States, Nevada
      Las Vegas, Nevada, United States, 89102
United States, New Jersey
CNS Research Institute    
      Clementon, New Jersey, United States, 08021
United States, Pennsylvania
Quantum Clinical Services Group    
      Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Community Clinical Research    
      Austin, Texas, United States, 78729
Future Search Trials    
      Austin, Texas, United States, 78756
Claghorn-Lesem Research Clinic    
      Bellaire, Texas, United States, 77401
InSite Clinical Research    
      DeSoto, Texas, United States, 75115
United States, Virginia
CBH Health, L.L.C - Dominion Hospital    
      Falls Church, Virginia, United States, 22044

Sponsors and Collaborators
Sumitomo Pharmaceuticals America
  More Information

Study ID Numbers:   D1050196
First Received:   July 30, 2004
Last Updated:   July 9, 2008
ClinicalTrials.gov Identifier:   NCT00088634
Health Authority:   United States: Food and Drug Administration

Keywords provided by Sumitomo Pharmaceuticals America:
Schizophrenia  

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 05, 2008




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