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SGLT2 Inhibitor

SGLT2 Inhibitor for Depression

Phase 2
Recruiting
Led By Dan V Iosifescu, MD, MMSc
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current/acute Major Depressive Disorder (MDD) diagnosis, per MINI psychiatric interview;
Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6
Awards & highlights

Summary

This trial is testing whether empagliflozin, a medication that helps produce ketone bodies, can reduce depression symptoms. It targets people with depression by providing an alternative energy source for the brain, potentially improving their mood.

Who is the study for?
This trial is for adults aged 18-65 with a current diagnosis of Major Depressive Disorder (MDD), who can provide written consent. It's not suitable for those with personality disorders, liver or kidney disease, hypersensitivity to empagliflozin, history of diabetic ketoacidosis, multiple anti-depressant treatment failures, neurologic/seizure disorders, or psychotic conditions.
What is being tested?
The study tests if empagliflozin (an SGLT2 inhibitor) reduces depression symptoms by making ketone bodies as alternative brain fuel. Participants will receive this medication and their mood changes will be observed.
What are the potential side effects?
Empagliflozin may cause urinary tract infections, dehydration leading to low blood pressure, genital yeast infections in women and men, increased cholesterol levels and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Major Depressive Disorder recently.
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I have signed the consent form approved by the NYU IRB.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Secondary study objectives
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951
15%
Cardiac failure
7%
Hypotension
7%
Hypertension
7%
Urinary tract infection
6%
Hyperkalaemia
6%
Renal impairment
6%
Fall
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Hyperuricaemia
4%
Anaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Death
2%
COVID-19
2%
Acute myocardial infarction
2%
Cardiac failure congestive
1%
Cardiac failure chronic
1%
Syncope
1%
Chronic kidney disease
1%
COVID-19 pneumonia
1%
Basal cell carcinoma
1%
Ischaemic stroke
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Cellulitis
1%
Myocardial infarction
1%
Sepsis
1%
Transient ischaemic attack
1%
Angina unstable
1%
Cerebrovascular accident
1%
Angina pectoris
1%
Ventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Major Depressive Disorder (MDD)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include selective serotonin reuptake inhibitors (SSRIs), which increase serotonin levels in the brain, and serotonin-norepinephrine reuptake inhibitors (SNRIs), which boost both serotonin and norepinephrine. These neurotransmitters are crucial for mood regulation. Another class, tricyclic antidepressants (TCAs), also increase neurotransmitter levels but with more side effects. Monoamine oxidase inhibitors (MAOIs) prevent the breakdown of neurotransmitters, increasing their availability. These mechanisms are vital as they help correct the chemical imbalances thought to underlie depression. Recently, SGLT2 inhibitors like empagliflozin are being studied for their potential to reduce depressive symptoms by increasing ketone bodies, providing an alternative energy source for the brain, which may be beneficial in energy metabolism disturbances seen in depression.
Fluoxetine induces glucose uptake and modifies glucose transporter palmitoylation in human peripheral blood mononuclear cells.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?Metabolite profiling of antidepressant drug action reveals novel drug targets beyond monoamine elevation.

Find a Location

Who is running the clinical trial?

American Society of Clinical PsychopharmacologyUNKNOWN
NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,149 Total Patients Enrolled
22 Trials studying Depression
1,586 Patients Enrolled for Depression
Dan V Iosifescu, MD, MMScPrincipal InvestigatorNYU Langone Health

Media Library

Empagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05757791 — Phase 2
Depression Research Study Groups: Participants with Major Depressive Disorder (MDD)
Depression Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05757791 — Phase 2
Empagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757791 — Phase 2
~6 spots leftby Oct 2025