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

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: NCT00195780
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 2, 2007
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Divalproex Sodium (Depakote ER) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety

Secondary Outcome Measures :
  1. Y-MRS
  2. CGI-S
  3. C-GAS
  4. CDRS-R
  5. CGSQ
  6. responders
  7. remitters

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00195780

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Sponsors and Collaborators
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Study Director: Global Medical Information Abbott

Layout table for additonal information Identifier: NCT00195780     History of Changes
Other Study ID Numbers: M03-647
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 2, 2007
Last Verified: June 2007

Keywords provided by Abbott:
Bipolar I Disorder

Additional relevant MeSH terms:
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Pathologic Processes
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