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

NYU Langone Health

Status and phase: Enrolling; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Empagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT05757791

23-00027

Details and patient eligibility

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Participants with Major Depressive Disorder (MDD)

Experimental group

Description:

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:

Drug: Empagliflozin