NCT00347152

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?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Kansas · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Divalproex	Divalproex, 8-20% taper
DRUG	Divalproex	Divalproex, 8-20% taper

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-07-04
• Last updated: 2008-09-12

Locations

1 site across 1 country: United States