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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 |
| 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 | |
More Information
| Study ID Numbers: | D1050196 |
| Study First Received: | July 30, 2004 |
| Last Updated: | July 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00088634 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Schizophrenia |
|
Schizophrenia Mental Disorders Psychotic Disorders Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
|
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |
