A Pilot Phase II Open-Label Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder

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A Pilot Phase II Open-Label Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder

Brief description of study

This is an open-label, single arm clinical trial preliminarily testing the antidepressant effects of empagliflozin in patients with major depressive disorder (MDD), and assessing its feasibility, safety and tolerability in this patient population. The study aims to enroll 16 subjects, and will collect clinical and laboratory data at screen, baseline, weeks 2, 4 and 6 (the endpoint). The primary outcome will be change in depression severity, compared to baseline, following drug administration as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). In exploratory analysis, we will study the relationship between ketogenesis and response, as well as the effect of treatment on markers of brain bioenergetic metabolism and neural insulin resistance by studying differences in the molecular cargo of brain derived exosomes before and after administration of the study drug.

Clinical Study Identifier: s23-00027

ClinicalTrials.gov Identifier: NCT05757791

Principal Investigator: Dan Iosifescu.

Other Investigator: David Liebers.

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