Risperidone Beats Lithium and Divalproex for Pediatric Bipolar Disorder

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. 

John Koutras, MD

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. 

Reference

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.

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This entry was posted on Tuesday, June 5th, 2012 at 9:12 am and is filed under Bipolar Disorder, Medications, Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

One Response to “Risperidone Beats Lithium and Divalproex for Pediatric Bipolar Disorder”

  1. David Rettew says:
    June 5, 2012 at 2:06 pm

    I think it is worth noting that the study was funded by NIMH and not a pharmaceutical company. That said, the disclosure section of the study takes up an entire manuscript page. — David Rettew

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