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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347152
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : September 12, 2008
Information provided by:
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Divalproex Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Active Comparator: 2
Slow Progressive Divalproex DR to Divalproex ER switch
Drug: Divalproex
Divalproex, 8-20% taper
Other Name: Depakote

Active Comparator: 1
Immediate, Progressive Divalproex DR to Divalproex ER switch
Drug: Divalproex
Divalproex, 8-20% taper
Other Name: Depakote

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347152

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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
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Principal Investigator: Jessica Hellings, MD University of Kansas Medical Center
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Responsible Party: Jessica Hellings, MD, University of Kansas Medical Center Identifier: NCT00347152    
Other Study ID Numbers: 10399
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: September 12, 2008
Last Verified: September 2008
Keywords provided by University of Kansas Medical Center:
Intellectual disabilities
development disabilities
behavior disorders
stable epilepsy
Additional relevant MeSH terms:
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Intellectual Disability
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs