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

Completed · Not applicable

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00347152

Run by

University of Kansas

People needed

18

Starts

2006-11-01

Expected to finish

2007-12-01

Last updated by the study team

2008-09-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.