Behavioral Disturbance, Epilepsy
Conditions
Keywords
Tolerability, Depakote DR, Depakote ER, Elderly, Conversion
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERapid versus slow conversion
Sponsors
Abbott
Veterans Affairs Medical Center, Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 60 yo and older on stable dose of valproate (Depakote DR)
Exclusion criteria
* Unstable neurolgical, medical or psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between group comparisons of GI and CNS side effect burden | — |
Secondary
| Measure | Time frame |
|---|---|
| Between group comparison of Quality of Life as measured bye the QOLIE-89 | — |
| Between group comparison of trough Total and Free valproic acid serum levels | — |
Countries
United States
Contacts
Primary ContactRenato Seguro, MD
Backup ContactTrichia Ramsay
Outcome results
None listed