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SGLT2 Inhibitor
SGLT2 Inhibitor for Depression
Phase 2
Recruiting
Led By Dan V Iosifescu, MD, MMSc
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current/acute Major Depressive Disorder (MDD) diagnosis, per MINI psychiatric interview;
Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6
Awards & highlights
Study Summary
This trial studies how a medication may reduce depression symptoms by helping the brain use ketones as an alternate energy source.
Who is the study for?
This trial is for adults aged 18-65 with a current diagnosis of Major Depressive Disorder (MDD), who can provide written consent. It's not suitable for those with personality disorders, liver or kidney disease, hypersensitivity to empagliflozin, history of diabetic ketoacidosis, multiple anti-depressant treatment failures, neurologic/seizure disorders, or psychotic conditions.Check my eligibility
What is being tested?
The study tests if empagliflozin (an SGLT2 inhibitor) reduces depression symptoms by making ketone bodies as alternative brain fuel. Participants will receive this medication and their mood changes will be observed.See study design
What are the potential side effects?
Empagliflozin may cause urinary tract infections, dehydration leading to low blood pressure, genital yeast infections in women and men, increased cholesterol levels and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Major Depressive Disorder recently.
Select...
I have signed the consent form approved by the NYU IRB.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Secondary outcome measures
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score
Side effects data
From 2021 Phase 3 trial • 5988 Patients • NCT0305795115%
Cardiac failure
7%
Hypertension
7%
Urinary tract infection
7%
Hypotension
6%
Hyperkalaemia
6%
Fall
6%
Renal impairment
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Anaemia
4%
Hyperuricaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Acute myocardial infarction
2%
COVID-19
2%
Cardiac failure congestive
2%
Death
1%
Myocardial infarction
1%
Cardiac failure chronic
1%
Angina pectoris
1%
Angina unstable
1%
Ventricular tachycardia
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Sepsis
1%
Chronic kidney disease
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Basal cell carcinoma
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Major Depressive Disorder (MDD)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750
Find a Location
Who is running the clinical trial?
American Society of Clinical PsychopharmacologyUNKNOWN
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,710 Total Patients Enrolled
21 Trials studying Depression
1,486 Patients Enrolled for Depression
Dan V Iosifescu, MD, MMScPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Major Depressive Disorder recently.You are allergic to empagliflozin or any of the ingredients in JARDIANCE.I have signed the consent form approved by the NYU IRB.I have had diabetic ketoacidosis in the past.I've had two or more unsuccessful treatments for my current depression episode.I have a history of neurological or seizure disorders.I am between 18 and 65 years old.The clinician who is evaluating you believes that you have a primary diagnosis of a personality disorder.I have a history of liver or kidney disease.I have been diagnosed with a mental health condition like Bipolar, Schizophrenia, or similar.I have been diagnosed with Major Depressive Disorder recently.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Major Depressive Disorder (MDD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What types of people are best suited for participation in this medical experiment?
"Admission to this trial is limited to those suffering from depression who are of legal age and younger than 65. 16 subjects need be enrolled in total."
Answered by AI
Is this experiment targeting people over the age of 25?
"Participants in this trial are expected to have an age range of 18-65 years old. There is a total of 192 studies that cater towards those younger than 18, and 985 for patients older than 65."
Answered by AI
Are there still openings available for participants in this experiment?
"According to information on clinicaltrials.gov, this study is not seeking participants at the moment. Despite having initially been posted in April of 2023 and updated as recently as February 24th, it does not have any active recruitment campaigns running presently; however, there are 1306 other trials that patients can take part in."
Answered by AI
Has the FDA authorized patients with Major Depressive Disorder (MDD) to receive this treatment?
"There is some evidence of safety for those with Major Depressive Disorder (MDD), thus this trial was rated a 2. As it stands, data in support of efficacy has yet to be generated."
Answered by AI
Who else is applying?
What state do they live in?
Florida
New York
Ohio
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
NYU Langone Health
Why did patients apply to this trial?
I want to make positive changes in my life. I take medication now and im interested in new medication.
PatientReceived 2+ prior treatments
I just hope yall can help me with my depression so I can get better. I want to help myself and others getting best treatment as possible.
PatientReceived 1 prior treatment
Hopefully get the answers and proper treatment hopefully something will work.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- NYU Langone Health: < 48 hours
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