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| Sponsored by: |
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
Show 35 Study Locations| 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 |
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Neurotransmitter Agents Tranquilizing Agents Olanzapine Risperidone Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Antimanic Agents Serotonin Uptake Inhibitors |
Valproic Acid Serotonin Schizophrenia Dopamine Mental Disorders Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Schizophrenia and Disorders with Psychotic Features Anticonvulsants |
|
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 |