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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Divalproex
* Drug: Divalproex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Slow Progressive Divalproex DR to Divalproex ER switch | Drug: Divalproex<br>* Divalproex, 8-20% taper<br>* Other names: Depakote;|
| Active Comparator: 1<br>Immediate, Progressive Divalproex DR to Divalproex ER switch | Drug: Divalproex<br>* Divalproex, 8-20% taper<br>* Other names: Depakote;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intellectual disabilities, development disabilities, behavior disorders, stable epilepsy