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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Major Depressive Disorder
  • Age: Between 18 Year(s) - 65 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
      In order to be eligible to participate in this study, an individual must meet all of the following criteria:
    1. Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB).
    2. Patients ages 18-65.
    3. Current/acute MDD diagnosis, per MINI psychiatric interview.
    4. At least moderate severity of depression (Montgomery-Asberg Depression Rating Scale (MADRS) score of =20 at initial screen).

You may not be eligible for this study if the following are true:

    1. An individual who meets any of the following criteria will be excluded from participation in this study:
    2. DSM-5 diagnosis of Bipolar disorders, Cyclothymia, Schizoaffective disorder, Schizophrenia; any psychotic disorder or affective psychosis.
    3. Individuals who have had more than two failures of adequate anti-depressant trials in the current MDD episode.
    4. Individuals on 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).
    5. Individuals who have previously been on SGLT2 inhibitors.
    6. A significant history of non-adherence to treatments.
    7. History of neurologic/seizure disorder.
    8. History of dementia/cognitive dysfunction.
    9. A primary diagnosis of a personality disorder, in the opinion of the screening clinician.
    10. DSM-5 substance use disorder (drug/alcohol) active within the past 12 months, or positive urine toxicology at screening.
    11. History of diabetic ketoacidosis.
    12. History of recurrent genital mycotic infection.
    13. GFR <45.
    14. HgA1c >8.0%.
    15. History of an allergic reaction to an SGLT2 inhibitor.
    16. Pregnancy or lactation (women of reproductive age, ie <50 years old, should be on licensed hormonal or barrier method contraception).
    17. Any known pancreatic disease resulting in insulin deficiency.
    18. History of liver or kidney disese.
    19. Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.

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