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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00071253 |
The purpose of this study is to assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: Divalproex Sodium (Delayed-Release Tablets) Drug: Divalproex Sodium (Extended-Release Tablets) Drug: Olanzapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study of Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Synergy Clinical Research | |
Chula Vista, California, United States, 91910 | |
Behavioral and Medical Research, LLC | |
Anaheim, California, United States, 92805 | |
United States, Florida | |
Segal Institute for Clinical Research | |
North Miami, Florida, United States, 33161 | |
Segal Institute for Clinical Research | |
North Miami, Florida, United States, 33161 | |
Clinical Trial Management | |
Fort Meyers, Florida, United States, 33907 | |
United States, Illinois | |
Rush Presbyterian - St. Luke's | |
Chicago, Illinois, United States, 60612 | |
United States, Kentucky | |
University of Louisville Outpatient Psychiatry | |
Louisville, Kentucky, United States, 40202 | |
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216 | |
United States, Nebraska | |
Creighton University Department of Psychiatry | |
Omaha, Nebraska, United States, 68131 | |
United States, Nevada | |
Lake Mead Hospital | |
North Las Vegas, Nevada, United States, 89030 | |
United States, New York | |
NYU School of Medicine | |
New York City, New York, United States, 10016 | |
United States, Ohio | |
R. Ranjan, MD & Associates, Inc. | |
Lyndhurst, Ohio, United States, 44124 | |
University Hospital of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United States, Oklahoma | |
IPS Research | |
Oklahoma City, Oklahoma, United States, 73103 | |
United States, Texas | |
UTMB Dept. of Psychiatry | |
Galveston, Texas, United States, 77555-0197 | |
United States, Wisconsin | |
Zablocki VAMC | |
Milwaukee, Wisconsin, United States, 53295 |
Study Director: | Global Medical Information | Abbott |
Study ID Numbers: | M02-551 |
Study First Received: | October 16, 2003 |
Last Updated: | August 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00071253 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bipolar Disorder - Mania |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Olanzapine Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Antimanic Agents |
Serotonin Uptake Inhibitors Valproic Acid Serotonin Affective Disorders, Psychotic Mental Disorders Mood Disorders Psychotic Disorders Peripheral Nervous System Agents Anticonvulsants |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Valproic Acid Affective Disorders, Psychotic Mental Disorders Therapeutic Uses Tranquilizing Agents Bipolar Disorder Gastrointestinal Agents |
Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Mood Disorders GABA Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |