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

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Mar 17, 2023

Status verified

Dec 2025

Primary completion

Apr 30, 2026

Completion

May 31, 2026

Study Design

Enrollment

16 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Participants with Major Depressive Disorder (MDD)
  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.

Primary Outcome Measure

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline, Week 6 ]

Central Contacts

• Dan V Iosifescu, MD, MMSc
  (646) 754-5156
  [email protected]
• David T Liebers, MD, MPhil, MPP
  212-263-7419
  [email protected]

Locations (1)

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