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.