Major Depressive DisorderPhase 2NCT05757791
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
A Phase 2 study testing Empagliflozin in people with Major Depressive Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2023to 6 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Phase II, Open-Label, Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Empagliflozin
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
The full duration of therapy will be six-weeks. The route of administration will be oral. The starting dose of the medication will be 10mg daily for the first 14 days of the study, with a dose escalation to 25mg for the last 28 days of the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Major Depressive Disorder (MDD) | Experimental | 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. Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
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."
Measured: Baseline, Week 6
Secondary outcomes (2)
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) - 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention.
Measured: Baseline, Week 6
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score
14- item questionnaire assessing four domains of pleasure response, aimed as a scale to measure anhedonia, or the inability to experience pleasure. Each item is rated on a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score is the sum of responses and ranges from 14 to 56; higher scores indicate lesser anhedonia.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start17 Mar 2023
- Primary completion6 Jun 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Psychopharmacology
- Responsible party
- Sponsor
- Investigators
- Dan V Iosifescu, MD, MMSc, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757791
- Sponsor's protocol ID
- 23-00027
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to David.Liebers@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Phase II, Open-Label, Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05757791
- Acronym / sponsor ID
- 23-00027
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- American Society of Clinical Psychopharmacology
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Major Depressive Disorder (MDD) | Experimental | Drug: EmpagliflozinPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: JardianceThe full duration of therapy will be six-weeks. The route of administration will be oral. The starting dose of the medication will be 10mg daily for the first 14 days of the study, with a dose escalation to 25mg for the last 28 days of the study. | Drug | Participants with Major Depressive Disorder (MDD) |
Primary outcome
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."
2 secondary outcomes
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Baseline, Week 6
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score
Time frame: Baseline, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to David.Liebers@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan V Iosifescu, MD, MMSc principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin in people with Major Depressive Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.