A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
- Conditions
- Bipolar I Disorder
- Registration Number
- NCT00195780
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Y-MRS CGI-S C-GAS CDRS-R CGSQ responders remitters
Trial Locations
- Locations (26)
Kolin Research Group
🇺🇸Winter Park, Florida, United States
Clinco
🇺🇸Terre Haute, Indiana, United States
Rakesh Ranjan, M.D. & Associates, Inc.
🇺🇸Lyndhurst, Ohio, United States
Pharmasite Research
🇺🇸Baltimore, Maryland, United States
Brentwood Research Institute
🇺🇸Shreveport, Louisiana, United States
Neuro Behavioral Clinical Research, INC.
🇺🇸Canton, Ohio, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Northlake Medical Research Center
🇺🇸Decatur, Georgia, United States
Acadia Hospital
🇺🇸Bangor, Maine, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Mountain West Clinical Trials
🇺🇸Eagle, Idaho, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
PCSD Feighner Research
🇺🇸San Marcos, California, United States
R/D Clinical Research
🇺🇸Lake Jackson, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Cientifica Inc.
🇺🇸Newton, Kansas, United States
Odyssey Research
🇺🇸Fargo, North Dakota, United States
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
Red Oak Psychiatry
🇺🇸Houston, Texas, United States
Psychiatric Professional Services
🇺🇸Cincinnati, Ohio, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
North Carolina Neuropsychiatry, PA
🇺🇸Chapel Hill, North Carolina, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
UTHSC, Sept. of Psychiatry, College of Medicine
🇺🇸Memphis, Tennessee, United States
Clinical Trials Specialists
🇺🇸Bala Cynwyd, Pennsylvania, United States