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

NCT ID: NCT00347152

Last Updated: 2008-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-12-31

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.

Conditions

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Epilepsy

Keywords

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Intellectual disabilities development disabilities behavior disorders stable epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

Slow Progressive Divalproex DR to Divalproex ER switch

Group Type ACTIVE_COMPARATOR

Divalproex

Intervention Type DRUG

Divalproex, 8-20% taper

1

Immediate, Progressive Divalproex DR to Divalproex ER switch

Group Type ACTIVE_COMPARATOR

Divalproex

Intervention Type DRUG

Divalproex, 8-20% taper

Interventions

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Divalproex

Divalproex, 8-20% taper

Intervention Type DRUG

Divalproex

Divalproex, 8-20% taper

Intervention Type DRUG

Other Intervention Names

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Depakote Depakote

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

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University of Kansas Medical Center

Principal Investigators

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Jessica Hellings, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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10399

Identifier Type: -

Identifier Source: org_study_id