Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Purpose
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.
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- NYU Langone Health
