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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas
• Collaborator: Abbott
• Treatments: Valproic Acid

Criteria

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