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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00034580 |
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: olanzapine Drug: risperidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion:
Study ID Numbers: | 5528, F1D-US-HGJT |
Study First Received: | April 30, 2002 |
Last Updated: | July 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00034580 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bipolar I Disorder |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Olanzapine Risperidone Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Serotonin Affective Disorders, Psychotic Dopamine Mental Disorders Mood Disorders Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Serotonin Antagonists Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Disease Tranquilizing Agents |
Bipolar Disorder Gastrointestinal Agents Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Mood Disorders Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |