A Pilot, Phase II, Open-Label, Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Empagliflozin (Drug)
Outcomes
Primary Outcomes
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time Frame: Baseline, Week 6
10-item physician-rated scale assessing depressive symptomology. Each item is rated on a Likert scale ranging from 0 to 6. The total score is the sum of responses and ranges from 0 to 60; higher scores indicate greater depressive symptomology. Specifically, a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression); a score ranging from 7 to 19 indicates "mild depression;" 20 to 34 indicates "moderate depression;" a score of 35 and greater indicates "severe depression;" and a total score of 60 or greater indicates "very severe depression."
Secondary Outcomes
- Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score(Baseline, Week 6)
- Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score(Baseline, Week 6)