The Treatment of Early Age Mania (TEAM) study was designed to investigate initial treatment of bipolar I disorder, manic or mixed phase, in treatment-naïve children and adolescents.

Subjects were aged 6- to 15-year-old children and adolescents with DSM-IV bipolar I disorder (manic or mixed phase) and were randomised to lithium, divalproex sodium, or risperidone. Medications were titrated weekly only if there was inadequate response, and no dose-limiting adverse effects, to maximum doses of lithium carbonate (1.1-1.3 mEq/L), divalproex sodium (111-125 μg/mL), and risperidone (4-6 mg).

The primary outcome measures were the Clinical Global Impressions for Bipolar Illness Improvement–Mania and the Modified Side Effects Form for Children and Adolescents.

A total of 279 subjects met the inclusion criteria. The mean age of subjects was 10.1 years and 50.2% were female. All patients had elated mood and/or grandiosity, 77.1% had psychosis, 97.5% had mixed mania, 99.3% had daily rapid cycling, and the mean mania duration was 4.9 years.

The following results were reported:

• The mean titrated lithium level was 1.09 mEq/L, and the mean divalproex sodium level was 113.6 μg/mL. The mean titrated risperidone dose was 2.57 mg.

• Higher response rates occurred with risperidone vs lithium (68.5% vs 35.6%; P < 0.001) and vs divalproex sodium (68.5% vs 24.0%; P < 0.001). Response to lithium vs divalproex sodium did not differ.

• The discontinuation rate was higher for lithium than for risperidone (P = 0.011).

• Increased weight gain, body mass index, and prolactin level occurred with risperidone vs lithium and vs divalproex sodium.

• The thyrotropin level increased in subjects taking lithium.

The authors concluded that although risperidone was more efficacious than lithium or divalproex sodium for the initial treatment of childhood mania although it was associated with potentially serious metabolic effects.