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

Treatment of Early Age Mania (TEAM) Study

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.

Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

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