Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability

Overnight Versus Progressive Conversion of Multiple Daily Dose Enteric-Coated Divalproex to Once-Daily Divalproex Extended Release: Which Strategy is Better Tolerated by Patients With Intellectual Disabilities?

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.

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