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Recruiting NCT05757791

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

Phase II Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot, Phase II, Open-Label, Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder

Overview

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.

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.

Primary outcome measures

  • Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score [Time frame: Baseline, Week 6]
Secondary outcome measures (2)
  • Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score [Time frame: Baseline, Week 6]
  • Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score [Time frame: Baseline, Week 6]

Eligibility criteria

Inclusion criteria

  • 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);

Exclusion criteria

  • 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.
  • Pregnancy or lactation (women of reproductive age, ie <50 years old, should be on licensed hormonal or barrier method contraception).
  • Any known pancreatic disease resulting in insulin deficiency (T1D, history of pancreatitis, pancreatic surgery);
  • History of liver or kidney disease;
  • Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05757791 · 23-00027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗