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

Sponsor:	Sunovion
Information provided by (Responsible Party):	Sunovion
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: Lurasidone 20 mg Drug: Lurasidone 40 mg Drug: Lurasidone 80mg	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) 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 Sunovion:

Primary Outcome Measures:

Number of Participants With Adverse Events [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.

Enrollment:	98
Study Start Date:	September 2002
Study Completion Date:	November 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lurasidone 20 mg Lurasidone 20 mg oral tablet	Drug: Lurasidone 20 mg Lurasidone 20mg oral tablet taken once daily for 6-months
Experimental: Lurasidione 40 mg Lurasidone 40 mg oral tablet	Drug: Lurasidone 40 mg Lurasidone 40mg oral tablets taken once daily
Experimental: Lurasidone 80mg Lurasidone 80mg oral tablet	Drug: Lurasidone 80mg Lurasidone 80mg oral tablet taken once daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Successful completion of participation in 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, Alabama
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, United States, 35209
United States, California
Institute for Psychopharmacology Research
Cerritos, California, United States, 90703
CNS Network
Garden Grove, California, United States, 92845
California Clinical Trials Medical Group
Glendale, California, United States, 91206
Optimum Health Services
La Mesa, California, United States, 91942
University of California, Irvine
Orange, California, United States, 92868
California Neuropsychopharmacology Clinical Research Institute
San Diego, California, United States, 92126
United States, District of Columbia
Psychiatric Institute of Washington
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
University of South Florida
Tampa, Florida, United States, 33613
Coordinated Research of Florida, Inc
Winter Park, Florida, United States, 32789
United States, Hawaii
Hawaii Research Center
Honolulu, Hawaii, United States, 96826
United States, Illinois
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States, 60194
American Medical Research
Oakbrook, Illinois, United States, 60523
United States, Nevada
Lake Mead Hospital
North Las Vegas, Nevada, United States, 89030
United States, New Jersey
Comprehensive Clinical Research, CNS
Clementon, New Jersey, United States, 08021
ClinSearch, Inc.
Kenilworth, New Jersey, United States, 07033
United States, Pennsylvania
Quantum Clinical Services Group
Philadelphia, Pennsylvania, United States, 19139
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
FutureSearch Trials
Austin, Texas, United States, 78756
Community Clinical Research
Austin, Texas, United States, 78756
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, United States, 77401
St. Paul Medical Center
Dallas, Texas, United States, 75235
United States, Virginia
CNS, Inc.
Falls Church, Virginia, United States, 22041
United States, Wisconsin
Medstream, Inc.
Milwaukee, Wisconsin, United States, 53210

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

Medical Director, MD

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00044005 History of Changes
Other Study ID Numbers:	D1050174
Study First Received:	August 16, 2002
Results First Received:	February 16, 2011
Last Updated:	September 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Schizophrenia
Latuda
Lurasidone

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012