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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Divalproex, 8-20% taper
Divalproex, 8-20% taper
University of Kansas Medical Center
Kansas City, Kansas, United States
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)
Time frame: Baseline to day +8
seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;
Time frame: Baseline to day + 8
total valproic acid serum levels (trough of pre-dose measurements)
Time frame: Prior to conversion, 1 week post conversion
changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel
Time frame: Prior to and one week post conversion
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