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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00195780 |
The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.
Condition | Intervention | Phase |
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Bipolar I Disorder |
Drug: Divalproex Sodium (Depakote ER) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents |
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Medical Information | Abbott |
Study ID Numbers: | M03-647 |
Study First Received: | September 14, 2005 |
Last Updated: | June 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00195780 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bipolar I Disorder Depakote |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants |
Antimanic Agents Valproic Acid Anticonvulsants |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Valproic Acid Pharmacologic Actions Pathologic Processes Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |