NCT05757791CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 24 Feb 2023
- Start date
- 17 Mar 2023
- Primary completion date
- 6 Jun 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Depression
- NCT number
- NCT05757791
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 17 Mar 2023 to the primary completion date, 6 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects on psychotropic medications other than SSRIs, NDRIs, SNRIs, or mirtazapine (occasional use of sleep agents, equivalent to lorazepam 1 mg or zolpidem 10 mg, will be allowed);
- Those that have previously been on SGLT2 inhibitors;
Other illness
- DSM-5 diagnosis of Bipolar disorders, Cyclothymia, Schizoaffective disorder, Schizophrenia; any psychotic disorder or affective psychosis;
- A significant history of non-adherence to treatments;
- History of neurologic / seizure disorder;
- A significant history of non-adherence to treatments;
- History of dementia/cognitive dysfunction (MOCA \< 22);
- A primary diagnosis of a personality disorder, in the opinion of the screening clinician;
- DSM-5 substance use disorder (drug/alcohol) active within the past 12 months, or positive urine toxicology at screening;
- History of diabetic ketoacidosis;
- History of recurrent genital mycotic infection;
- History of an allergic reaction to an SGLT2 inhibitor.
- Any known pancreatic disease resulting in insulin deficiency (T1D, history of pancreatitis, pancreatic surgery);
- History of liver or kidney disease;
- Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.
Lab values
- GFR \<45;
Age
- Pregnancy or lactation (women of reproductive age, ie \<50 years old, should be on licensed hormonal or barrier method contraception).
Other
- Subjects that have had more than two failures of adequate anti-depressant trials in the current MDD episode;
- HgA1c.\>8.0%
Who the study is looking for
- Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB).
- Patients ages 18-65;
- Current/acute Major Depressive Disorder (MDD) diagnosis, per MINI psychiatric interview;
- At least moderate severity of depression (Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 at initial screen);
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.