Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Recruiting · NCT05757791 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- NYU Langone Health - New York, New York, United States