Actively Recruiting
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Led by NYU Langone Health · Updated on 2025-12-03
16
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
A
American Society of Clinical Psychopharmacology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent as approved by the NYU Institutional Research Ethic Board (IRB)
- Age between 18 and 65 years
- Current acute diagnosis of Major Depressive Disorder confirmed by MINI psychiatric interview
- Moderate or severe depression with a Montgomery-5sberg Depression Rating Scale (MADRS) score of at least 20 at initial screening
You will not qualify if you...
- Diagnosis of Bipolar disorder, Cyclothymia, Schizoaffective disorder, Schizophrenia, any psychotic disorder or affective psychosis
- More than two failures of adequate antidepressant trials in the current depressive episode
- Use of psychotropic medications other than SSRIs, NDRIs, SNRIs, or mirtazapine (except occasional sleep agents like lorazepam 1 mg or zolpidem 10 mg)
- Previous use of SGLT2 inhibitors
- Significant history of non-adherence to treatments
- History of neurologic or seizure disorder
- Dementia or cognitive dysfunction (MOCA score less than 22)
- Primary diagnosis of a personality disorder as determined by the screening clinician
- Active substance use disorder within the past 12 months or positive urine toxicology at screening
- History of diabetic ketoacidosis
- History of recurrent genital mycotic infection
- Estimated glomerular filtration rate (GFR) less than 45
- Hemoglobin A1c greater than 8.0%
- History of allergic reaction to an SGLT2 inhibitor
- Pregnancy or lactation; women under 50 must use licensed hormonal or barrier contraception
- Known pancreatic disease causing insulin deficiency (type 1 diabetes, pancreatitis, pancreatic surgery)
- History of liver or kidney disease
- Hypersensitivity to empagliflozin or its excipients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
D
Dan V Iosifescu, MD, MMSc
CONTACT
D
David T Liebers, MD, MPhil, MPP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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