Status:
RECRUITING
Combination of Novel Therapies for CKD Comorbid Depression
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Kidney Diseases
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The overall goal of the study is to determine if treatment of a Major Depressive Disorder (MDD) improves the outcomes of patients with chronic kidney disease (CKD). We showed that MDD is present in 25...
Detailed Description
Aim 1. Compare the efficacy and tolerability of two 16-week strategies vs. control for treatment of CKD patients with MDD starting with (1) BAT or (2) bupropion, each augmented to a combination of bot...
Eligibility Criteria
Inclusion
- Male or female adults aged 18 years or greater. There will be no upper age limit.
- Presence of CKD stages 3b, 4 or 5, with an estimated glomerular filtration rate (GFR) of \<45 mL/min/1.73 m2 for a period of at least 3 months, as defined by the National Kidney Foundation and determined using the four-variable Modification of Diet for Renal Diseases Study formula.
- Presence of a current Major Depressive Disorder (MDD) based on MINI DSM IV-based criteria
- Quick Inventory of Depressive Symptomatology-Self-report (QIDS-SR) score of ≥11 at enrollment and ≥11 on QIDS-Clinician Rated (QIDS-C) at randomization.
- Able to understand and sign informed consent after the nature of the study has been fully explained
- Kidney transplant patients that are at least 6 month post-transplantation (3 months post-transplant, with at least another 3 months to confirm eGFR \<45)
Exclusion
- Unable to understand or give informed consent.
- Unwilling or unable to participate in the protocol or comply with any of its components
- Significant hepatic dysfunction or liver enzyme abnormalities 3 times or greater than the upper limit of normal
- Terminal chronic obstructive pulmonary disease or cancer
- Presence of seizure disorder
- Current use of class I anti-arrhythmic medications (such as 1C propafenone and flecanide), pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine, or methyldopa; tri-cyclic anti-depressants, neuroleptics, or anti-convulsants
- Use of serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.
- Use of medications known to cause QT prolongation on EKG
- Ongoing use of antidepressant medications for depression treatment
- Past treatment failure on bupropion
- Initiation of depression-focused psychotherapy in the 3 months prior to study entry
- Active alcohol or substance abuse or dependence that requires acute detoxification at study entry
- Present or past psychosis or Bipolar I or II disorder
- Dementia or a Mini-Mental State Examination score \<23
- Active suicidal intent
- Pregnancy, lactation, or women of childbearing potential not willing to use adequate contraception
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04422652
Start Date
September 24 2020
End Date
April 1 2027
Last Update
November 28 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8430
2
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
3
UT Southwestern and Affiliates
Dallas, Texas, United States, 75390
4
University of Washington
Seattle, Washington, United States, 98195