An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

August 2, 2006 updated by: Abbott

A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents

The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Childrens National Medical Center
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Miami, Florida, United States, 33161
        • Professional Clinical Research, Inc.
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83704
        • Mountain West Clinical Trials
    • Illinois
      • Libertyville, Illinois, United States, 60031
        • Capstone Clinical Research
    • Kansas
      • Newton, Kansas, United States, 67114
        • Cientifica Inc at Praire View, Inc.
    • Kentucky
      • Lexington, Kentucky, United States, 40509
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU - Health Science Center
      • Shreveport, Louisiana, United States, 71101
        • Brentwood Research Institute
    • Michigan
      • Clinton Township, Michigan, United States
        • New Oakland Child/Adoles and Family Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Mercy Health Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Cutting Edge Research Group
    • Texas
      • Galveston, Texas, United States, 77705
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77058
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  • Current primary diagnosis of bipolar I disorder, mania or mixed type
  • Outpatient between 10 and 17 years of age
  • Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1

EXCLUSION CRITERIA

  • Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
  • Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism)
  • Expected to require hospitalization for the current manic episode
  • Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated
  • Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms
  • Unable to swallow tablets
  • Has received depot psychoactive medication within one inter-injection interval of Day 1
  • Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines
  • History of alcohol or substance dependence within past 3 mos. or substance abuse within past month
  • History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months
  • Has taken Depakote (DR or ER) regularly for the current manic episode
  • Has serious violent, homicidal, or suicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline to the final evaluation in Y-MRS score.

Secondary Outcome Measures

Outcome Measure
Adverse events
Vital signs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Global Medical Information, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Registration Dates

First Submitted

August 13, 2003

First Submitted That Met QC Criteria

August 14, 2003

First Posted (Estimate)

August 15, 2003

Study Record Updates

Last Update Posted (Estimate)

August 4, 2006

Last Update Submitted That Met QC Criteria

August 2, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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