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Maintenance lithium treatment shows potential for pediatric bipolar disorder

Lithium demonstrated tolerability and safety as a maintenance treatment in pediatric patients with bipolar disorder for 28 weeks, study findings showed.

“There are limited prospective long-term pharmacological treatment data for bipolar disorder in children and adolescents. Previous prospective data in the pediatric age group have generally been restricted to combination pharmacotherapy studies,” Robert L. Findling, MD, MBA, of Johns Hopkins University, and colleagues wrote. “Only a modest amount of information exists based on double-blind, placebo-controlled data regarding the treatment of pediatric patients with lithium beyond 8 weeks.”

In a multicenter, double-blind, placebo-controlled study, the investigators evaluated the role of lithium as a maintenance treatment for patients aged 7 to 17 years with bipolar I disorder.

Participants presenting with a manic or mixed episode received 24 weeks of lithium treatment in one of two multiphase studies known as the Collaborative Lithium Trials. Youth who responded to treatment were then randomized to continue lithium or to be cross titrated to placebo for up to 28 weeks. Primary endpoint was relative risk of study discontinuation for any reason in groups receiving lithium vs. placebo.

Analysis of the primary efficacy endpoint revealed that the 17 pediatric patients who continued treatment with lithium had a lower hazard ratio than the 14 patients who received placebo after adjusting for age (HR = 0.28; 95% CI, 0.1–0.78). Most discontinuations due to mood symptom exacerbations occurred in the placebo-treated group; five participants receiving lithium vs. 10 receiving placebo discontinued treatment due to mood symptoms (HR = 0.24 95% CI, 0.08–0.74).

In total, 15 patients taking lithium and nine taking placebo reported at least one adverse event.

Most adverse events were mild to moderate in severity, and the most frequent event for participants in both groups was headache. Only one participant discontinued due to a serious adverse event (aggression), according to the researchers. In addition, Findling and colleagues observed no statistically significant difference in weight gain between participants receiving lithium and those receiving placebo.

“Lithium treatment for the study duration demonstrated good tolerability. However, efficacy and safety over a longer period of time is an empiric question that remains unanswered in this patient population,” the researchers wrote. “Therefore, additional longer and larger studies that can more definitively evaluate the efficacy of lithium for the long-term treatment of pediatric bipolar disorder are needed.” – by Savannah Demko

Disclosures: Findling reports research support, acting as a consultant, and/or serving on a speaker’s bureau for Aevi, Akili, Alcobra, Amerex, the American Academy of Child and Adolescent Psychiatry, American Psychiatric Press, Bracket, Epharma Solutions, Forest, Genentech, Ironshore, KemPharm, Lundbeck, NIH, Neurim, Nuvelution, Otsuka, the Patient-Centered Outcomes Research Institute, Pfizer, Physicians Postgraduate Press, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Syneurx, Teva, Tris, TouchPoint and Validus. Please see the study for all other authors’ relevant financial disclosures.