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Lithium reduces manic symptoms of pediatric bipolar I disorder

Data from a prospective, randomized, double blind, placebo-controlled trial show that lithium reduced manic symptoms among youth with bipolar I disorder.

“Lithium has long been a benchmark treatment of adults with bipolar I disorder. Despite lithium’s use for bipolar I disorder in adults, definitive placebo-controlled, methodologically stringent studies of efficacy have not been available for children,” Robert L. Findling, MD, MBA, of Johns Hopkins University/Kennedy Krieger Institute, Baltimore, and colleagues wrote.

To study efficacy and safety of lithium for pediatric bipolar I disorder, researchers randomly assigned individuals aged 7 to 17 years with bipolar I disorder with manic or mixed episodes to receive lithium (n = 53) or placebo (n = 28) for up to 8 weeks.

Study participants receiving lithium exhibited significantly larger changes in Young Mania Rating Scale (YMRS) scores from baseline to week 8 compared with those receiving placebo (P = .03). When adjusting for baseline YMRS score, age group, weight group, gender and study site, treatment effect size was 5.51 (95% CI, 0.51-10.5).

Children’s Global Assessment Scale scores increased, indicating improved global functioning, among both treatment groups. There was no statistically significant difference between groups in Clinical Global Impression-Severity scores (P = .11).

However, Clinical Global Impression-Improvement scores favored lithium compared with placebo at week 8 (P = .03).

Seven serious adverse events occurred, five in the lithium group and two in the placebo group, though the researchers report none of the serious adverse events were related to study medication.

“Lithium exhibited efficacy in the acute treatment of pediatric bipolar I disorder. With the dosing regimen used, lithium was found to have a generally acceptable adverse effect profile. Although use of the sustained-release formulation of lithium may obviate vomiting, this question is empirical and has not yet been tested,” the researchers concluded. – by Amanda Oldt

Disclosure: Findling reports receiving research support, acting as as a consultant, and/or serving on a speakers bureau for Alcobra, the American Academy of Child and Adolescent Psychiatry, the American Physician Institute, American Psychiatric Press, AstraZeneca, Bracket, Bristol-Myers Squibb, CogCubed, Cognition Group, Coronado Biosciences, the Dana Foundation, Elsevier, Forest, GlaxoSmithKline, Guilford Press, Johnson and Johnson, Jubilant Clinsys, KemPharm, Lilly, Lundbeck, Merck, Neurim, Novartis, Noven, Otsuka, Oxford University Press, Pfizer, Physicians Postgraduate Press, Purdue, Rhodes Pharmaceuticals, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Transcept Pharmaceuticals, Validus, and WebMD. Please see the full study for a list of all authors’ relevant financial disclosures.