RECRUITING

Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)

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Conditions

Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-17
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05757791

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB).
  2. * Patients ages 18-65;
  3. * Current/acute Major Depressive Disorder (MDD) diagnosis, per MINI psychiatric interview;
  4. * At least moderate severity of depression (Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 at initial screen);
  1. * DSM-5 diagnosis of Bipolar disorders, Cyclothymia, Schizoaffective disorder, Schizophrenia; any psychotic disorder or affective psychosis;
  2. * Subjects that have had more than two failures of adequate anti-depressant trials in the current MDD episode;
  3. * 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);
  4. * Those that have previously been on SGLT2 inhibitors;
  5. * A significant history of non-adherence to treatments;
  6. * History of neurologic / seizure disorder;
  7. * A significant history of non-adherence to treatments;
  8. * History of dementia/cognitive dysfunction (MOCA \< 22);
  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 (T1D, history of pancreatitis, pancreatic surgery);
  18. * History of liver or kidney disease;
  19. * Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.

Contacts and Locations

Study Contact

Dan V Iosifescu, MD, MMSc
CONTACT
(646) 754-5156
dan.iosifescu@nyulangone.org
David T Liebers, MD, MPhil, MPP
CONTACT
212-263-7419
david.liebers@nyulangone.org

Principal Investigator

Dan V Iosifescu, MD, MMSc
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Dan V Iosifescu, MD, MMSc, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-17
Study Completion Date2025-08

Study Record Updates

Study Start Date2023-03-17
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder