Back to resultsSodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Empagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
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.
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with Major Depressive Disorder (MDD)
Arm Description
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.
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05757791
First Posted
February 24, 2023
Last Updated
April 6, 2023
Sponsor
NYU Langone Health
Collaborators
American Society of Clinical Psychopharmacology
1. Study Identification
Unique Protocol Identification Number
NCT05757791
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
American Society of Clinical Psychopharmacology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with Major Depressive Disorder (MDD)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Empagliflozin
Other Intervention Name(s)
Jardiance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Description
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."
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Description
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.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score
Description
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.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan V Iosifescu, MD, MMSc
Phone
(646) 754-5156
Email
dan.iosifescu@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
David T Liebers, MD, MPhil, MPP
Phone
212-263-7419
Email
david.liebers@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan V Iosifescu, MD, MMSc
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Iosifescu, MD, MMSc
Phone
646-754-5156
Email
dan.iosifescu@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.Liebers@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
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