eLi12: Optimising Lithium Treatment for Bipolar Disorder

Lithium is recommended as the first-line treatment choice for patients with bipolar disorder. However, to ensure patient safety, the lithium blood concentration must be checked regularly and maintained within a narrow interval. Slightly higher concentrations can lead to intoxication and organ damage, while too-low concentrations can lead to relapse and a high risk of suicide.

The Inspiration Behind the Innovation

For over 50 years, the blood concentration measured 12 hours after the last lithium dose has guided psychiatrists’ decisions regarding the optimal lithium dosage for each patient. Known as 'the 12-hour serum lithium level' (se-Li), this method is often inaccurate and yields misleading results due to timing-related logistical challenges. Statistically, more than 75 percent of these routine blood tests are taken at a time that's outside the 12 hours after the patient's last dose. As a result, the psychiatrist must make an educated guess about the probable 12-hour se-Li. This discrepancy can be problematic if, for example, a lithium level measured 16 hours after the last dose is interpreted as a '12-hour level' leading to an unnecessary and potentially dangerous increase in dosage.

The Innovation 

Research performed by Ole Köhler Forsberg shows that there's a clinically relevant difference in Li blood level just before and after the last dose.

Data from a large patient group has been used to develop a formula that can accurately calculate se-Li based on existing data points. This will provide psychiatrists with a tool that can improve treatment of patients with biopolar disorder.

During the BETA.HEALTH period, the project team has verified an initial prototype using data from Danish patients. They've also initiated regulatory approval and clinical implementation. In addition, they've established a close collaboration with Lars Beck Thomsen at Trustworks as an IT-development partner with the expertise to support the implementation of the formula into daily clinical practice at the Bipolar Clinic at AUH. The project has also received substantial support in establishing an implementation study for the formula from the Central Denmark Region's IT Department at Aarhus University as well as the Psychiatry Department and the Bipolar Clinic at AUH.

The Team

Ole Köhler-Forsberg: MD, PhD, Associate Professor; Bipolar Clinic – Aarhus University Hospital Psychiatry Department; Psychosis Research Unit – Aarhus University

Lars Albert Beck Thomsen: Managing Partner, Business Architect; Trustworks