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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05757791
Phase
PHASE2
Status
Completed

Conditions

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

First listed
Mar 7, 2023
Start date
Mar 17, 2023
Status verified
Aug 2026
Primary completion
Jun 6, 2026
Completion
Jun 6, 2026

Study Design

Enrollment
20 participants (actual)
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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

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By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
NYU Langone Health· New York, NY

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