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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00300963 |
The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Talnetant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia |
Estimated Enrollment: | 275 |
Study Start Date: | December 2004 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, Arkansas | |
GSK Investigational Site | |
Little Rock, Arkansas, United States, 72201 | |
United States, California | |
GSK Investigational Site | |
Garden Grove, California, United States, 92845 | |
GSK Investigational Site | |
Oceanside, California, United States, 92056 | |
GSK Investigational Site | |
Pico Rivera, California, United States, 90660 | |
GSK Investigational Site | |
Glendale, California, United States, 91206 | |
GSK Investigational Site | |
Rosemead, California, United States, 91770 | |
GSK Investigational Site | |
Anaheim, California, United States, 92805 | |
GSK Investigational Site | |
Cerritos, California, United States, 90703 | |
GSK Investigational Site | |
Upland, California, United States, 91786 | |
GSK Investigational Site | |
San Diego, California, United States, 92123 | |
GSK Investigational Site | |
National City, California, United States, 91950 | |
United States, District of Columbia | |
GSK Investigational Site | |
Washington, District of Columbia, United States, 20016 | |
United States, Florida | |
GSK Investigational Site | |
North Miami, Florida, United States, 33161 | |
United States, Georgia | |
GSK Investigational Site | |
Atlanta, Georgia, United States, 30308 | |
United States, Missouri | |
GSK Investigational Site | |
St. Louis, Missouri, United States, 63118 | |
United States, New Jersey | |
GSK Investigational Site | |
Clementon, New Jersey, United States, 08021 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Philadelphia, Pennsylvania, United States, 19131 | |
United States, Texas | |
GSK Investigational Site | |
Irving, Texas, United States, 75062 | |
GSK Investigational Site | |
Austin, Texas, United States, 78756 | |
United States, Virginia | |
GSK Investigational Site | |
Richmond, Virginia, United States, 23294 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 223412/093 |
Study First Received: | March 7, 2006 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00300963 |
Health Authority: | United States: Food and Drug Administration |
psychosis cognition |
Schizophrenia Dopamine Mental Disorders Risperidone |
Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |