A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

June 29, 2007 updated by: Abbott

An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

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
      • San Diego, California, United States, 92111
        • PCSD Feighner Research
      • San Marcos, California, United States, 92078
        • PCSD Feighner Research
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Ft. Lauderdale, Florida, United States, 33319
        • Segal Institute for Clinical Research
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • Winter Park, Florida, United States, 32789
        • Kolin Research Group
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Northlake Medical Research Center
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Mountain West Clinical Trials
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Clinco
    • Kansas
      • Newton, Kansas, United States, 67114
        • Cientifica Inc.
      • Overland Park, Kansas, United States, 66211
        • Psychiatric Associates
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Brentwood Research Institute
    • Maine
      • Bangor, Maine, United States, 04402-0422
        • Acadia Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • PharmaSite Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • North Carolina Neuropsychiatry, PA
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Odyssey Research
    • Ohio
      • Canton, Ohio, United States, 44708
        • Neuro Behavioral Clinical Research, Inc.
      • Cincinnati, Ohio, United States, 45267-0559
        • Psychiatric Professional Services
      • Lyndhurst, Ohio, United States, 44124
        • Rakesh Ranjan, M.D. & Associates, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Cutting Edge Research Group
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004-1604
        • Clinical Trials Specialists
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • UTHSC, Sept. of Psychiatry, College of Medicine
    • Texas
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center

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:

  • Subject is between 10 and 17 years of age, inclusive, on Day 1 and weighs at least 60 lbs (27 kg).
  • Subject has a current psychiatric diagnosis of bipolar I disorder, manic or mixed episode, based on the K-SAD-PL interview and DSM-IV-TR criteria.
  • Subject is an outpatient in a manic or mixed episode with a YMRS score of greater than or equal to 16 during Screening and at Day 1.

Exclusion Criteria:

  • Has an Axis I disorder other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder, Enuresis, Encopresis, Parasomnias, Agoraphobia, Specific Phobia, Social Phobia or Separation Anxiety Disorder; or subject has an Axis II disorder that would interfere with the subject's ability to comply with study procedures or confound interpretation of the study results. Subject meets DSM-IV-TR criteria for substance abuse within the month prior to Screening, or meets the criteria for substance dependence within the three months prior to Screening, or exhibits signs of drug or alcohol intoxication or withdrawal at Day 1.
  • Is expected to require hospitalization for the current manic or mixed episode.
  • Is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others.
  • Has a history of a chronic or acute medical disorder that, in the opinion of the investigator, would preclude compliance with the protocol, or confound interpretation of the study results.
  • Has a history of, or is suspected of having a seizure disorder.
  • Has any central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease.
  • Has Platelet count less than or equal to 100,000/µL
  • Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening.
  • Is taking a protocol allowed medication for ADHD that has not been stable for at least 3 months prior to Day 1, or that, in the investigator's opinion, may be exacerbating mood symptoms.
  • Requires anticoagulant drug therapy.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety

Secondary Outcome Measures

Outcome Measure
CGI-S
Y-MRS
C-GAS
CDRS-R
CGSQ
responders
remitters

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

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

February 1, 2005

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 2, 2007

Last Update Submitted That Met QC Criteria

June 29, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-647

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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