NEW YORK – The University of California, Irvine Institute of Interdisciplinary Salivary Bioscience Research announced today it has received a five-year, $1 million gift from the Elisabeth Severance Prentiss Foundation to expand research into the use of saliva to monitor lithium levels in patients with bipolar and major depressive disorders.
While lithium is an effective and affordable long-term treatment for bipolar disorder, only about 25 percent of patients are treated with it because of its "very narrow therapeutic window," IISBR Director, UCI Chancellor's Professor of psychological science and coprincipal investigator on the study Douglas Granger said in a statement. He added that lithium must also be monitored closely for efficacy and safety.
Lithium testing has been done with patients' blood, but saliva offers several advantages, UC Irvine said, including its noninvasive nature and ease of collection. Results from prior research on saliva-based testing were inconclusive because of a lack of standardization in collection and storage procedures, and inconsistent processing methods, but new methodologies and point-of-care testing technology have overcome some of the obstacles, according to coprincipal investigator Elizabeth Thomas.
Preliminary research from IISBR — started in 2017 with a $150,000 gift from the Prentiss Foundation — demonstrated a strong positive association between serum and salivary lithium measurements. With the new gift, further work will increase the number of patients in the work to 300 from 40, including children, while the number of study sites will be expanded to four from one.
The research will be conducted in three phases. In the first phase, saliva will be confirmed as an accurate measure of lithium levels in an extended cohort of patients. Also, differences in absorption and distribution throughout the body will be observed; excretion variations will be identified; and changes in drug levels throughout a day will be measured.
Based on those results, in Phase II, criteria will be established to determine whether commercially available rapid blood testing equipment can be modified for use with saliva. In Phase III, a point-of-care device will be developed specifically for use with saliva for use in a clinical setting.
"Rapid tests would have enormous value in determining drug levels in the body for efficacy and safety, as well as establishing patient compliance in taking their medication," Thomas said. "We believe our findings will dramatically improve drug monitoring in this important patient populatio