Could a Sugar-Lowering pill lift your mood?
NCT ID NCT05757791
First seen Jun 26, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This small study tests whether empagliflozin (Jardiance), a diabetes medication, can reduce symptoms of major depression. The drug helps the body produce ketones, which may provide an alternative energy source for the brain. Sixteen adults with moderate to severe depression will take the pill daily for six weeks, and researchers will track changes in their mood and suicidal thoughts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin (Jardiance)
- What this could lead to
- If it works, this could point toward a new treatment option for depression using a diabetes drug.
- What could go wrong
- This is a very small, early-phase trial with only 16 people and no placebo group, so results may not be reliable or generalizable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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); Exclusion Criteria: * DSM-5 diagnosis of Bipolar disorders, Cyclothymia, Schizoaffective disorder, Schizophrenia; any psychotic disorder or affective psychosis; * Subjects that have had more than two failures of adequate anti-depressant trials in the current MDD episode; * 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; * 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; * GFR \<45; * HgA1c.\>8.0% * History of an allergic reaction to an SGLT2 inhibitor. * Pregnancy or lactation (women of reproductive age, ie \<50 years old, should be on licensed hormonal or barrier method contraception). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
NYU Langone Health
New York, New York, 10016, United States
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