Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Lithium Carbonate; Risperidone; Valproic Acid

Criteria

Inclusion Criteria:

• DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks

• CGAS less than or equal to 60

• Good physical health

Exclusion Criteria:

• Schizophrenia or any pervasive developmental disorder

• Major medical or neurological disease

• History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks

• IQ less than 70

• Pregnancy or breast-feeding

• Unacceptable methods of contraception

• In-patient care at baseline