Safety and Tolerability Study of Drug to Treat Schizophrenia - Full Text View

Sponsor:	Sumitomo Pharmaceuticals America
Information provided by:	Sumitomo Pharmaceuticals America
ClinicalTrials.gov Identifier:	NCT00044005

Purpose

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: SM-13496	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 in Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Lurasidone SM-13496

U.S. FDA Resources

Further study details as provided by Sumitomo Pharmaceuticals America:

Estimated Enrollment:	150
Study Start Date:	September 2002
Estimated Study Completion Date:	December 2003

Eligibility

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

Criteria

Inclusion criteria:

Successful completion of participation in Sumitomo protocol #D1050049

Exclusion criteria:

Substance abuse
Prolactin level of ≥200ng/mL at baseline
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044005

Locations

United States, California
Optimum Health Services
La Mesa, California, United States, 91942
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Institute for Psychopharmacology Research
Cerritos, California, United States, 90703
Affiliated Research Institute
San Diego, California, United States, 92108
United States, District of Columbia
Comprehensive Neuroscience. Inc.
Washington, District of Columbia, United States, 20016
United States, Florida
Comprehensive Neuroscience. Inc.
Melbourne, Florida, United States, 32935
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Carman Research
Smyrna, Georgia, United States, 30080
United States, Hawaii
Hawaii Research Center
Honolulu, Hawaii, United States, 96826
United States, Illinois
American Medical Research
Oakbrook, Illinois, United States, 60523
United States, Maryland
Centers for Behavioral Health, LLC
Rockville, Maryland, United States, 20850
United States, New Jersey
ClinSearch, Inc.
Kenilworth, New Jersey, United States, 07033
Comprehensive Clinical Research CNS, PC
Clementon, New Jersey, United States, 08021
United States, Pennsylvania
Quantum Clinical Services Group
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
Community Clinical Research
Austin, Texas, United States, 78756
University Hills Clinical Research
Dallas, Texas, United States, 75235
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, United States, 77401
United States, Virginia
CNS, Inc.
Falls Church, Virginia, United States, 22041
United States, Washington
Northwest Clinical Research Center
Belleview, Washington, United States, 98004

Sponsors and Collaborators

Sumitomo Pharmaceuticals America

More Information

No publications provided

Study ID Numbers:	D1050174
Study First Received:	August 16, 2002
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00044005 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sumitomo Pharmaceuticals America:

SM-13496
Schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009