A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
NCT ID: NCT00195780
Last Updated: 2007-07-02
Study Results
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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COMPLETED
PHASE3
227 participants
INTERVENTIONAL
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Divalproex Sodium (Depakote ER)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
17 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Global Medical Information
Role: STUDY_DIRECTOR
Abbott
Locations
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PCSD Feighner Research
San Diego, California, United States
PCSD Feighner Research
San Marcos, California, United States
Altamonte Springs, Florida, United States
Segal Institute for Clinical Research
Fort Lauderdale, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Kolin Research Group
Winter Park, Florida, United States
Northlake Medical Research Center
Decatur, Georgia, United States
Mountain West Clinical Trials
Eagle, Idaho, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Clinco
Terre Haute, Indiana, United States
Cientifica Inc.
Newton, Kansas, United States
Psychiatric Associates
Overland Park, Kansas, United States
Brentwood Research Institute
Shreveport, Louisiana, United States
Acadia Hospital
Bangor, Maine, United States
Pharmasite Research
Baltimore, Maryland, United States
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, United States
Odyssey Research
Fargo, North Dakota, United States
Neuro Behavioral Clinical Research, INC.
Canton, Ohio, United States
Psychiatric Professional Services
Cincinnati, Ohio, United States
Rakesh Ranjan, M.D. & Associates, Inc.
Lyndhurst, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Clinical Trials Specialists
Bala-Cynwyd, Pennsylvania, United States
UTHSC, Sept. of Psychiatry, College of Medicine
Memphis, Tennessee, United States
InSite Clinical Research
DeSoto, Texas, United States
Red Oak Psychiatry
Houston, Texas, United States
R/D Clinical Research
Lake Jackson, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Other Identifiers
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M03-647
Identifier Type: -
Identifier Source: org_study_id