| Home | Search | Study Topics | Glossary |
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| Sponsored by: |
Sumitomo Pharmaceuticals America |
| Information provided by: | Sumitomo Pharmaceuticals America |
| ClinicalTrials.gov Identifier: | NCT00088621 |
Purpose
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
| Condition | Intervention | Phase |
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Schizophrenia |
Drug: SM-13496 |
Phase II |
| MedlinePlus related topics: | Schizophrenia |
| ChemIDplus related topics: | SM-13496 Lurasidone |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2005 |
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.
Eligibility
| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and 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 | |||||
| Collaborative Neuro Science Network, Inc. | |||||
| Garden Grove, California, United States, 92845 | |||||
| Comprehensive NeuroScience | |||||
| Cerritos, California, United States, 90703 | |||||
| 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 | |||||
| Segal Institute for Clinical Research | |||||
| North Miami, Florida, United States, 33161 | |||||
| University of South Florida, Department of Psychiatry and Behavioral Medicine | |||||
| Tampa, Florida, United States, 33613 | |||||
| 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 | |||||
| Claghorn Lesem Research Clinic, Inc. | |||||
| Bellaire, Texas, United States, 77401 | |||||
| Community Clinical Research | |||||
| Austin, Texas, United States, 78729 | |||||
| Future Search Trials | |||||
| Austin, Texas, United States, 78756 | |||||
| InSite Clinical Research | |||||
| Desoto, Texas, United States, 75115 | |||||
| United States, Virginia | |||||
| CBH Health, L.L.C - Dominion Hospital | |||||
| Falls Church, Virginia, United States, 22044 | |||||
| Sumitomo Pharmaceuticals America |
More Information
Site provides an overview of the study, inclusion / exclusion criteria, general information about schizophrenia, and resources related to schizophrenia.
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| Study ID Numbers: | D1050199 |
| First Received: | July 30, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00088621 |
| Health Authority: | United States: Food and Drug Administration |
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