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

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Drug: Divalproex

• Registration Number: NCT00347152
• Lead Sponsor: University of Kansas

Brief 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.

Study Timeline

• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Study Start: 2006-11
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-10
• Last Update Posted: 2008-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Divalproex	Slow Progressive Divalproex DR to Divalproex ER switch
1	Divalproex	Immediate, Progressive Divalproex DR to Divalproex ER switch

Primary Outcome Measures

Name	Time	Method
direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects)	Baseline to day +8

Secondary Outcome Measures

Name	Time	Method
seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;	Baseline to day + 8
total valproic acid serum levels (trough of pre-dose measurements)	Prior to conversion, 1 week post conversion
changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel	Prior to and one week post conversion

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States