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OpenTrials
Completed

NCT Number: NCT00347152

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

divalproex

Drug

Divalproex, 8-20% taper

Other names: Depakote

Primary outcomes

  1. 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)

    Time frame: Baseline to day +8

Secondary outcomes

  1. seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;

    Time frame: Baseline to day + 8

  2. total valproic acid serum levels (trough of pre-dose measurements)

    Time frame: Prior to conversion, 1 week post conversion

  3. changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel

    Time frame: Prior to and one week post conversion

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • Abbott

Registry information

Official study 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?

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 4, 2006
Registry last updated
Sep 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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