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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00195780
First received: September 14, 2005
Last updated: June 29, 2007
Last verified: June 2007
  Purpose

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 Intervention Phase
Bipolar I Disorder
Drug: Divalproex Sodium (Depakote ER)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Y-MRS
  • CGI-S
  • C-GAS
  • CDRS-R
  • CGSQ
  • responders
  • remitters

Enrollment: 227
Study Start Date: February 2005
  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195780

  Show 29 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195780     History of Changes
Other Study ID Numbers: M03-647
Study First Received: September 14, 2005
Last Updated: June 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Bipolar I Disorder
Depakote

Additional relevant MeSH terms:
Disease
Pathologic Processes
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014