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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00073164 |
Purpose
The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Divalproex Sodium Extended-Release Tablets Drug: Olanzapine Drug: Risperidone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia |
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2003 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
KEY INCLUSION CRITERIA:
KEY EXCLUSION CRITERIA:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States | |
| Tuscaloosa, Alabama, United States | |
| United States, California | |
| Anaheim, California, United States | |
| Cerritos, California, United States | |
| Los Angeles, California, United States | |
| Garden Grove, California, United States | |
| Glendale, California, United States | |
| Chula Vista, California, United States | |
| San Diego, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Florida | |
| Gainsville, Florida, United States | |
| Melbourne, Florida, United States | |
| North Miami, Florida, United States | |
| Winter Park, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| Hoffman Estates, Illinois, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| South Bend, Indiana, United States | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States | |
| United States, Maryland | |
| Rockville, Maryland, United States | |
| United States, Mississippi | |
| Jackson, Mississippi, United States | |
| United States, New Jersey | |
| Clementon, New Jersey, United States | |
| Kenilworth, New Jersey, United States | |
| United States, New York | |
| Holliswood, New York, United States | |
| New York, New York, United States | |
| United States, North Carolina | |
| Butner, North Carolina, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| Cleveland, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| San Antonio, Texas, United States | |
| Austin, Texas, United States | |
| Irving, Texas, United States | |
| United States, Virginia | |
| Falls Church, Virginia, United States | |
| Study Director: | Global Medical Information 800-633-9110 | Abbott |
More Information
| Study ID Numbers: | M02-547 |
| Study First Received: | November 17, 2003 |
| Last Updated: | August 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00073164 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Valproic Acid Schizophrenia Serotonin Antagonists Mental Disorders Therapeutic Uses Schizophrenia and Disorders with Psychotic Features Tranquilizing Agents Gastrointestinal Agents |
Risperidone Central Nervous System Depressants Enzyme Inhibitors Dopamine Antagonists Antimanic Agents Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents GABA Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |