RecruitingPhase 2NCT05757791

Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)

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


Sponsor

NYU Langone Health

Enrollment

16 participants

Start Date

Mar 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to determine whether empagliflozin, a medication in a class known as sodium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, may reduce symptoms of depression. Since this medication helps the body make metabolites known as ketone bodies which can serve as an alternate energy source for the brain, the investigators can also test whether ketone bodies help with depressed mood.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether empagliflozin (an SGLT2 inhibitor, a type of diabetes medication known for its anti-inflammatory effects), can improve symptoms of major depressive disorder (MDD) when added to standard antidepressant treatment. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with major depressive disorder (MDD) confirmed by a psychiatric interview - Your depression is at least moderately severe (based on a standard rating scale) **You may NOT be eligible if...** - You have bipolar disorder, cyclothymia, schizoaffective disorder, schizophrenia, or other psychotic conditions - You have type 1 diabetes or are at very high risk for diabetic ketoacidosis - You have significant kidney or liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin

The full duration of therapy will be six-weeks. The route of administration will be oral. The starting dose of the medication will be 10mg daily for the first 14 days of the study, with a dose escalation to 25mg for the last 28 days of the study.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT05757791


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