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Abstract
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Aims: Lithium is as a cornerstone treatment for bipolar disorder, effective across both acute and maintenance phases in adults and pediatric patients. Long-term use of lithium is linked to a significant reduction in suicide risk in adults. Despite its well-established efficacy, the use of lithium is underutilized, especially in the younger population, oftentimes due to the presumed risk of develosping chronic kidney disease. However, the data on lithium's safety in younger populations is limited, with a notable scarcity of pharmacokinetic and pharmacodynamic (PK/PD) studies and age-specific dosing guidelines.
Methods: This study details a comprehensive population PK/PD analysis using data from Phase I (an 8 week, open-label, randomized, escalating-dose study) and Phase II (a 16 week, open-label, long-term effectiveness trial) of the CoLT1 (Collaborative Lithium Trials) study. This includes lithium concentration-time profiles at single dose and steady state, trough concentrations, Wechsler Abbreviated Scale of Intelligence (WASI), thyroid function, and renal function measured over 24 weeks. While steady-state PK profiles, trough concentrations, and effectiveness scores over this period have been published, the relationship between these PK profiles, trough concentrations, and the longitudinal safety data has yet to be analyzed.
Discussion and conclusion: This is the first study to evaluate the safety parameters of lithium in children and adolescents. With access to the COLT1 data, we will expand on the investigators’ initial reports by undertaking a comprehensive PK/PD analysis. Our findings aim to describe the safety profile of lithium in pediatric populations, providing insights that could refine therapeutic strategies and enhance patient outcomes.
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