Clinical trial NCT00347152: Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Intellectual disabilities
development disabilities
behavior disorders
stable epilepsy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2006-07-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Baseline to day +8
Secondary outcomes:
measure: seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;
timeFrame: Baseline to day + 8
measure: total valproic acid serum levels (trough of pre-dose measurements)
timeFrame: Prior to conversion, 1 week post conversion
measure: changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel
timeFrame: Prior to and one week post conversion
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jessica Hellings, MD
role: PRINCIPAL_INVESTIGATOR
References: