by John Koutras, MD
A recent NIMH funded study in the May issue of the Archives of General Psychiatry found risperidone to be more efficacious than lithium or divalproex sodium for childhood mania.
The Treatment of Early Age Mania (TEAM) study comes from 5 centers across the country. The trial was a controlled, randomized, but open-labeled, no-patient-choice, 8-week parallel comparison of lithium carbonate, risperidone, and divalproex sodium among subjects who had not previously received medications for mania. Participants were outpatients aged 6 to 15 years with a DSM-IV diagnosis of bipolar I disorder, manic or mixed episode, with 77% of the sample deemed to have psychotic symptoms. Lithium was titrated to a level of 1.1 – 1.3 mEq/L, divalproex to 111 to 125 micrograms/mL, and risperidone was dosed generally in the 4 to 6 mg range. 279 subjects were randomized equally, 1:1:1, to each treatment. The primary outcome measure was the Clinical Global Impressions for Bipolar Illness Improvement-Mania (CGI-BP-IM).
Results showed that risperidone was significantly superior to lithium and divalproex sodium on the CGI-BP-IM. A total of 68.5% of risperidone treated subjects responded in comparison to 35.6% and 24% for the lithium and divalproex groups, respectively. While high discontinuation rates occurred in the lithium group, risperidone was associated with weight gain, hyperprolactinemia, and increased thyrotropin levels. Subjects in the risperidone group gained on average a little over 7 pounds. Also of note was that antidepressants were tapered in study participants (about 10%); however, this variable did not affect response rate.
Geller B, Luby J, et al. A randomized controlled trial of risperidone, lithium, or divalproex sodium for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents. Arch Gen Psychiatry 2012: 69 May: 515-528.