Epilepsy
Conditions
Keywords
Intellectual disabilities, development disabilities, behavior disorders, stable epilepsy
Brief summary
The purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they are switched to the extended release form (ER) overnight versus when they switch more gradually over a week.
Detailed description
Considering that there are potential advantages to once-daily depakote extended release in terms of decreased side effects, decreased medication errors and patient compliance, there is a need to determine the best method of conversion from multiple-daily dose delayed release depakote to once-daily for subjects with epilepsy bipolar disorder or behavior disorders.
Interventions
DRUGDivalproex
Divalproex, 8-20% taper
Sponsors
Abbott
University of Kansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients currently taking divalproex direct release for any seizure and/or behavior disorder * patients with intellectual disability * other medications for co-morbid disease are permitted, provided no plans for changes in medication used for the treatment of the disorder are expected
Exclusion criteria
* patients with a recent history of status epilepticus in the past 6 months * seizures in the past 3 months * patients with acute illness requiring changes in concurrent drugs * patients unwilling to change from their present direct release divalproex to divalproex extended release * patients that do not have a reliable caregiver * patients with lack of verbal expressive speech
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects) | Baseline to day +8 |
Secondary
| Measure | Time frame |
|---|---|
| seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale; | Baseline to day + 8 |
| total valproic acid serum levels (trough of pre-dose measurements) | Prior to conversion, 1 week post conversion |
| changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel | Prior to and one week post conversion |
Countries
United States
Outcome results
None listed