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Safety and Tolerability Study of Drug to Treat Schizophrenia

This study has been completed.
Information provided by (Responsible Party):
Sunovion Identifier:
First received: August 16, 2002
Last updated: March 31, 2014
Last verified: March 2014
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Condition Intervention Phase
Drug: Lurasidone 20 mg
Drug: Lurasidone 40 mg
Drug: Lurasidone 80mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 6-months ]
    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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Successful completion of participation in protocol #D1050049

Exclusion criteria:

  • Substance abuse
  • Prolactin level of ≥200ng/mL at baseline
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00044005

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
Community Clinical Research
Austin, Texas, United States, 78756
FutureSearch Trials
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
Study Director: Medical Director, MD Sunovion
  More Information

Responsible Party: Sunovion Identifier: NCT00044005     History of Changes
Other Study ID Numbers: D1050174
Study First Received: August 16, 2002
Results First Received: February 16, 2011
Last Updated: March 31, 2014

Keywords provided by Sunovion:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on March 29, 2017