Source: DGNews  |  Posted 3 years ago

By Laura Gater

CHICAGO -- November 4, 2008 -- Divalproex is efficacious for treatment of mixed or manic episode in children and adolescents with bipolar I disorder, but additional controlled trials are needed to demonstrate the efficacy of lithium in this population, according to a randomised, placebo-controlled study.

Investigator Robert L. Findling, MD, University Hospitals, Case Medical Center, Cleveland, Ohio, presented the study results here on October 31 at the American Academy of Child and Adolescent Psychiatry (AACAP) 55th Annual Meeting.

This study's main objective was to compare the efficacy of lithium, divalproex, and placebo for treatment of acute-phase mixed or manic episodes of symptomatic bipolar I disorder in children and adolescents.

The study enrolled 150 patients aged 7 to 17 years and randomised them to double-blind treatment with lithium, divalproex, or placebo in a 2:2:1 ratio. The primary outcome measures were weekly ratings on the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions - Improvement (CGI-I) scale.

Divalproex was efficacious in the acute phase, and there was a trend in the same direction for lithium.

Continuation/re-randomisation results are pending, according to Dr. Findling.

Mean weekly YMRS scores by group showed that by week 8, divalproex was significantly more effective than placebo (P < .01) and significantly more effective than lithium (P = .22).

Divalproex peaked at week 4, and by week 8, it had the lowest score on the YMRS.

At the 8-week evaluation, divalproex demonstrated efficacy on both outcome measures, the researchers pointed out. Although lithium had a definite trend towards efficacy, it did not clearly separate from placebo on the primary outcome measures (P = .12).

The researchers concluded that divalproex is efficacious for this age group with bipolar I disorder. Additional controlled trials are needed to demonstrate the efficacy of lithium in this population, they noted.

[Presentation title: The Efficacy of Lithium Versus Divalproex in Children and Adolescents With Bipolar I Disorder. Abstract 33.2]