A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
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
1 other identifier
interventional
227
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedJuly 2, 2007
June 1, 2007
September 14, 2005
June 29, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Secondary Outcomes (7)
Y-MRS
CGI-S
C-GAS
CDRS-R
CGSQ
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (29)
PCSD Feighner Research
San Diego, California, 92111, United States
PCSD Feighner Research
San Marcos, California, 92078, United States
Unknown Facility
Altamonte Springs, Florida, 32701, United States
Segal Institute for Clinical Research
Fort Lauderdale, Florida, 33319, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Kolin Research Group
Winter Park, Florida, 32789, United States
Northlake Medical Research Center
Decatur, Georgia, 30033, United States
Mountain West Clinical Trials
Eagle, Idaho, 83616, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Clinco
Terre Haute, Indiana, 47802, United States
Cientifica Inc.
Newton, Kansas, 67114, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Brentwood Research Institute
Shreveport, Louisiana, 71101, United States
Acadia Hospital
Bangor, Maine, 04402-0422, United States
Pharmasite Research
Baltimore, Maryland, 21208, United States
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, 27514, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Neuro Behavioral Clinical Research, INC.
Canton, Ohio, 44708, United States
Psychiatric Professional Services
Cincinnati, Ohio, 45267-0559, United States
Rakesh Ranjan, M.D. & Associates, Inc.
Lyndhurst, Ohio, 44124, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73120, United States
Clinical Trials Specialists
Bala-Cynwyd, Pennsylvania, 19004-1604, United States
UTHSC, Sept. of Psychiatry, College of Medicine
Memphis, Tennessee, 38105, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Red Oak Psychiatry
Houston, Texas, 77090, United States
R/D Clinical Research
Lake Jackson, Texas, 77566, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Information
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 20, 2005
Study Start
February 1, 2005
Last Updated
July 2, 2007
Record last verified: 2007-06