What is it about?

Lithium is a highly effective treatment for bipolar disorder, but finding the correct dose requires frequent blood tests, leading many patients to stop taking it due to the heavy monitoring burden. To address this, researchers have developed «PharmOracle», a smartphone and web application that helps doctors calculate personalized medication doses based on a patient's unique physical characteristics and ongoing blood test results. The app also sends automated reminders for taking medication and attending lab tests, while allowing patients to easily track and report side effects. This paper outlines the plan for a clinical trial that will test whether using this digital tool alongside standard care helps patients stay on their treatment longer and reduces the risk of hospital visits caused by incorrect dosing or mood relapses.

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Why is it important?

Despite being the most effective maintenance therapy for bipolar disorder, lithium use is declining globally due to the heavy burden of intensive monitoring and its narrow therapeutic window. Our work is unique as it outlines the first prospective randomized trial to evaluate Model-Informed Precision Dosing (MIPD) in psychiatry. Unlike conventional mental health applications that merely track symptoms, our proposed «PharmOracle» platform integrates population pharmacokinetic modeling, Bayesian dose refinement, and automated safety monitoring into a comprehensive clinical decision-support tool. This timely protocol aligns with newly established expert consensus criteria for evaluating digital mental health interventions. By personalizing dosing and streamlining care, this approach has the potential to significantly reduce treatment discontinuation and avoidable hospitalizations, establishing a foundational blueprint for applying precision pharmacology to other complex psychotropic medications.

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This page is a summary of: Protocol for a randomised controlled trial on smartphone- and web-based app for precision dosing and monitoring of lithium («PharmOracle») for improving adherence to therapy in patients with bipolar affective disorder or schizoaffective disorder, Neuroscience Applied, July 2026, Elsevier,
DOI: 10.1016/j.nsa.2026.107022.
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