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Sponsors and Collaborators: |
Joliet Center for Clinical Research Abbott |
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Information provided by: | Joliet Center for Clinical Research |
ClinicalTrials.gov Identifier: | NCT00211250 |
The purpose of this study is to compare compliance, tolerability, effectiveness, and side-effects in Bipolar I and II patients switching from Valproic Acid to Depakote ER.
Condition | Intervention | Phase |
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Mood Disorder |
Drug: Valproic Acid and Depakote ER |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Exploratory Study Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar I and II Patients From Valproic Acid to Depakote ER |
Estimated Enrollment: | 20 |
Study Start Date: | July 2005 |
Study Completion Date: | September 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Over the next year between 20 and 40 patients, who meet all inclusion and exclusion criteria, will be entered into the study. The treatment period of the study will last at least 10-13 weeks depending on how quickly your Depakote ER level reaches a therapeutic level (50-100mcg/mL).
At your first visit:
At this visit you will discontinue valproic acid and begin taking Depakote ER the following day. The total daily dose will be adjusted to be 8-20% higher than your original valproic acid dose, at the discretion of the Investigator, in order to reach therapeutic levels. Rating scales will be administered and the study drug (Depakote ER) will be dispensed.
Your study doctor or staff will explain the amount of medication you will receive, and will give you instructions on how to take it. It is important that your study drug is not taken by anyone else. Your study doctor and other study staff, whom you are to ask any questions about the study drug's effects and any side effects, will regularly check your response to treatment. If you get worse, the study drug dose may be changed, or you may be given additional medications, or the study drug may be stopped and you will be given another drug instead.
Before continuing to visit 3 you must reach a valproate level of 50-100mcg/mL. Weekly titration visits (T1-T4) will be scheduled and blood samples will be taken to test the Valproic level in your blood. The study doctor may adjust your dose, until a level of 50-100 mcg/ml is reached. If the above level is not reached within four weeks of visit 2, you will be discontinued from the study.
After the therapeutic level is reached, you will be asked to return in one week for visit 3, four weeks for visit 4, and another four weeks for the final visit, visit 5. Overall, your treatment with Depakote ER will be between 10-13 weeks in duration. During visits 3 and 4 the Depakote ER dose may be adjusted in 250mg or 500mg increments to maintain adequate level, to manage side effects and/or manage bipolar symptoms at the discretion of the study doctor. In addition, you will be asked to report any side effects and complete the psychiatric scales at each visit and blood samples will be taken at visits 3 and 5. (See the Schedule of Events for more details)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Cosme Lozano M.D. | |
Joliet, Illinois, United States, 60435 |
Principal Investigator: | Cosme O Lozano, M.D. | JCCR |
Responsible Party: | Joliet Center for Clinical research ( Cosme o. lozano, MD ) |
Study ID Numbers: | JCCR-001 |
Study First Received: | September 13, 2005 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00211250 History of Changes |
Health Authority: | United States: Institutional Review Board |
Depakote Er and Valproic Acid |
Neurotransmitter Agents Tranquilizing Agents Mental Disorders Psychotropic Drugs Mood Disorders |
Central Nervous System Depressants Antimanic Agents Valproic Acid Anticonvulsants |
Neurotransmitter Agents 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 Mental Disorders Therapeutic Uses Mood Disorders GABA Agents Central Nervous System Agents Anticonvulsants |