Status:
COMPLETED
Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Bipolar Disorder
Eligibility:
All Genders
10-20 years
Phase:
PHASE3
Brief Summary
The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.
Detailed Description
Pediatric Bipolar Disorder (PBD) severely impairs a child's emotional development, and is associated with alarming rates of suicide, school failure, aggression, risk taking behaviors and substance abu...
Eligibility Criteria
Inclusion
- Children with Bipolar Disorder
- Must be able to swallow tablets
Exclusion
- Children with general medical condition such as head injury, epilepsy, endocrine disorders
- Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
- If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.
- We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00176202
Start Date
April 1 2003
End Date
January 1 2008
Last Update
November 5 2015
Active Locations (3)
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1
Neuro Psychiatric Institute (NPI)
Chicago, Illinois, United States, 60612
2
NPI, University of Illinois at Chicago
Chicago, Illinois, United States, 60612
3
NPI
Chicago, Illinois, United States, 60612