Lithium was superior to placebo in reducing manic symptom in pediatric patients treated for bipolar I disorder (BP-I) and was generally well-tolerated, according to a new study in Pediatrics. These findings support the short-term effectiveness and safety of this medication in this patient population.

Robert Findling, MD, MBA, from the Johns Hopkins University School of Medicine and the Johns Hopkins Children’s Center, and colleagues conducted a multicenter, randomized, double-blind, placebo-controlled study of 81 pediatric patients aged 7–17 with BP-I/manic or mixed episodes, in which patients received either a regimen of lithium at a standard dose (gradually increasing to a maximum tolerated dose over the next eight weeks if mood symptoms weren’t controlled) or placebo. The primary endpoint was change from baseline to Week 8 in the Young Mania Rating Scale (YMRS) score, and other standard assessment tools for bipolar disorder symptoms and therapies were also applied. Patients were also questioned about side effects and given a physical exam that included a weight check.

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YMRS score changes were significantly greater in lithium-treated participants after adjustment for baseline YMRS score, age group, weight group, gender, and study site. About 47% of the patients taking lithium scored in the range of “very much improved” or “much improved” on the Clinical Global Impressions Scale, compared to 21% in the placebo arm. There was a statistically significant increase in thyrotropin concentration with lithium vs. placebo and no statistically significant difference in weight gain between the two groups.

Dr. Findling added that this research can help clinicians in determining the optimal medication for pediatric patients with bipolar disorder, with regards to short-term efficacy and risks.

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