Dosing strategies for lithium monotherapy in children and adolescents with bipolar I disorder
Department of Psychiatry
Adolescent; Antimanic Agents; Bipolar Disorder; Body Weight; Child; Dose-Response Relationship, Drug; Evidence-Based Medicine; Female; Humans; Lithium Carbonate; Male; Severity of Illness Index; Treatment Outcome
OBJECTIVE: The primary goal of this exploratory study was to obtain data that could lead to evidence-based dosing strategies for lithium in children and adolescents suffering from bipolar I disorder.
METHODS: Outpatients aged 7-17 years meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition, diagnostic criteria for bipolar I disorder (manic or mixed) were eligible for 8 weeks of open label treatment with lithium in one of three dosing arms. In Arm I, participants began treatment at a dose of 300 mg of lithium twice daily. The starting dose of lithium in Arms II and III was 300 mg thrice daily. Patients in Arms I and II could have their dose increased by 300 mg/day, depending on clinical response, at weekly visits. Patients in Arm III also had mid-week telephone interviews after which they could also have their dose of lithium increased by 300 mg per day. Youths weighing I, whereas youths weighing >/=30 kg were randomly assigned to Arm I, II, or III. Randomization was balanced by age (7-11 years, 12-17 years) and sex in approximately equal numbers. A priori response criteria were defined as a Clinical Global Impressions-Improvement scale score of /= 50% improvement in Young Mania Rating Scale score, and more than half of the patients (58%) achieved response. Overall, lithium was well tolerated. All three treatment arms had similar effectiveness, side effect profiles, and tolerability of lithium.
CONCLUSIONS: On the basis of these results, a dosing strategy in which pediatric patients begin lithium at a dose of 300 mg thrice daily (with an additional 300 mg increase during the first week), followed by 300 mg weekly increases until a priori stopping criteria are met, will be used in an upcoming randomized, placebo-controlled trial.
DOI of Published Version
J Child Adolesc Psychopharmacol. 2011 Jun;21(3):195-205. Link to article on publisher's site
Journal of child and adolescent psychopharmacology
Findling RL, Kafantaris V, Pavuluri M, McNamara NK, McClellan J, Frazier JA, Sikich L, Kowatch R, Lingler J, Faber J, Rowles BM, Clemons TE, Taylor-Zapata P. (2011). Dosing strategies for lithium monotherapy in children and adolescents with bipolar I disorder. Psychiatry Publications. https://doi.org/10.1089/cap.2010.0084. Retrieved from https://escholarship.umassmed.edu/psych_pp/521