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

Kansas Board of Regents

Status

Completed

Conditions

Epilepsy

Treatments

Drug: Divalproex

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00347152

10399

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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