Using empagliflozin to treat major depressive disorder

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

This study is testing if empagliflozin, a diabetes medication, can help people with major depressive disorder feel better by using a different energy source for their brains.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05757791 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of empagliflozin, a sodium-glucose cotransporter-2 inhibitor, on reducing symptoms of major depressive disorder (MDD). The approach focuses on the potential of ketone bodies, produced by the medication, to serve as an alternative energy source for the brain, which may alleviate depressive symptoms. Participants will be assessed for their depression severity and monitored throughout the treatment phase to evaluate changes in mood and overall mental health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a current diagnosis of major depressive disorder and moderate to severe symptoms.

Not a fit: Patients with bipolar disorder, psychotic disorders, or those who have previously failed multiple antidepressant treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from major depressive disorder.

How similar studies have performed: While the use of SGLT2 inhibitors for depression is a novel approach, other studies have explored metabolic interventions in mental health with varying degrees of success.

Eligibility criteria

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.

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Dan V Iosifescu, MD, MMSc — NYU Langone Health
• Study coordinator: Dan V Iosifescu, MD, MMSc

Conditions: Major Depressive Disorder