MedTrace Logo

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

NCT05757791 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

DRUG

Empagliflozin

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.

Sponsors & Collaborators

  • American Society of Clinical Psychopharmacology

    collaborator UNKNOWN

  • NYU Langone Health

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2026-04-30
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757791 on ClinicalTrials.gov