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

NCT05757791 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-00027
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

  10-item physician-rated scale assessing depressive symptomology. Each item is rated on a Likert scale ranging from 0 to 6. The total score is the sum of responses and ranges from 0 to 60; higher scores indicate greater depressive symptomology. Specifically, a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression); a score ranging from 7 to 19 indicates "mild depression;" 20 to 34 indicates "moderate depression;" a score of 35 and greater indicates "severe depression;" and a total score of 60 or greater indicates "very severe depression."

  Baseline, Week 6

Secondary Outcomes (2)

• Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score

  Baseline, Week 6

• Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score

  Baseline, Week 6

Study Arms (1)

Participants with Major Depressive Disorder (MDD)

EXPERIMENTAL

Patients will receive empagliflozin 10mg daily for two weeks and then empagliflozin 25mg for four weeks, for a total treatment duration of 6 weeks. Patients will be instructed to take the medication each morning, daily, with or without food. The number of doses given may be increased to a small degree to allow for flexibility in the scheduling of follow-up visits.

Drug: Empagliflozin

Interventions

Empagliflozin DRUG

The full duration of therapy will be six-weeks. The route of administration will be oral. The starting dose of the medication will be 10mg daily for the first 14 days of the study, with a dose escalation to 25mg for the last 28 days of the study.

Also known as: Jardiance

Participants with Major Depressive Disorder (MDD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Society of Clinical Psychopharmacology: collaborator
• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Dan V Iosifescu, MD, MMSc

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: March 17, 2023
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.Liebers@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)