Conditions: Bipolar Disorder
Keywords: Mania
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 379
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Participants will receive treatment with lithium for 8 to 16 weeks arm 2: Participants will receive treatment with valproate for 8 to 16 weeks arm 3: Participants will receive treatment with risperidone for 8 to 16 weeks

Interventions: intervention 1: Lithium carbonate intervention 2: Valproate intervention 3: Risperidone
Intervention descriptions: intervention 1: Titrated until blood level is 1.1 to 1.3 mEq/L intervention 2: Titrated until blood level is 111 to 125 ug/mL intervention 3: Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID

Protocol document: