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NCT05757791 · ClinicalTrials.gov registry record · Phase 2
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
A Phase 2 study of Major Depressive Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05757791: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by NYU Langone Health.
NCT05757791 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 16 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05757791, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 "seve
Conditions Studied
Interventions
- DRUG Empagliflozin
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT05757791 shows while recruiting
NCT05757791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Empagliflozin is the first listed.
NCT05757791 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05757791 about?
NCT05757791 is a clinical study titled "Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)". 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 a...
What is the current status of trial NCT05757791?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2023-03-17. Estimated completion is 2026-05.
What conditions does trial NCT05757791 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05757791?
The interventions under investigation include: Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT05757791?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05757791 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05757791's enrollment target sits among peer trials
16 257th of 282 higher than 23 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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