Could a Sugar-Lowering pill lift your mood?

NCT ID NCT05757791

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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