Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote
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ClinicalTrials.gov Identifier: NCT00312676
Verified March 2006 by Veterans Affairs Medical Center, Miami. Recruitment status was: Recruiting
The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.
Condition or disease
Procedure: Rapid versus slow conversion
Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.
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Ages Eligible for Study:
60 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
60 yo and older on stable dose of valproate (Depakote DR)
Unstable neurolgical, medical or psychiatric disorder