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| 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 |
| 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 |
| Estimated Enrollment: | 160 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | December 2004 |
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 |
Inclusion Criteria:
Exclusion Criteria:
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 | |||||
| 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 | |||||
| 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 |
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