Mental health technology developer Medibio Limited (ASX: MEB) reports that the first prospective clinical trial has begun with the prestigious Mayo Clinic under a 5-year Master Clinical Trial Agreement that was signed in October.
This initial study, undertakes the prospective diagnosis and longitudinal monitoring of both unipolar and bipolar depression, along with the depressive subtypes (melancholic and atypical).
The primary goal is to characterise longitudinal autonomic, circadian, and sleep patterns, as classified by the Medibio Analytics Platform (MAP), following the initiation of a standard pharmacological treatment for a new or recurrent, moderate-to-severe major depressive episode of both the unipolar and bipolar type.
Additionally, MAP will be used to characterize patterns unique to the bipolar type depression.
Jack Cosentino, Medibio’s CEO and Managing Director, said the research study team will be led by Mark A. Frye, M.D., at Mayo Clinic’s Rochester campus. Dr Frye, the chair of Mayo’s Department of Psychiatry and Psychology.
“We have been eager to get this initial study started with Dr Frye and Mayo Clinic, as this kicks off our first of many collaborations in mental health between our organisations,” Mr Consentino said.
“The importance of this study is to look at bipolar depression and differential diagnosis with our analytics platform, which can ultimately drive getting the right treatment to the right patient at the right time.
“Mayo remains a leading academic centre of excellence that the world looks to for innovative solutions to global problems.”
Dr Frye says the Mayo Clinic Depression Center has focused iyts research efforts on studies that have the potential to innovate our clinical practice; making a positive impact on patients’ lives.
It is estimated that 350 millon people worldwide suffer from depression. Depression is one of the leading causes of disability in the United States.
Two major challenges in the clinical practice of mood disorder is distinguishing major depressive disorder from bipolar depression and individualizing treatments for patients who struggle with depression.
As treatment options markedly differ in these two mood disorders, biomarkers to help accurate diagnosis and guide treatment would be of tremendous clinical value.