Clinical trial NCT05757791: Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Official title: A Pilot, Phase II, Open-Label, Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Psychopharmacology
First posted: 2023-03-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Baseline, Week 6
measure: Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Dan V Iosifescu, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: