Overview

Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Illinois at Chicago
Treatments:
Anticonvulsants
Antipsychotic Agents
Risperidone
Valproic Acid
Criteria
Inclusion Criteria:

- Children with Bipolar Disorder

- Must be able to swallow tablets

Exclusion Criteria:

- 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.