NCT04422652Active, not recruitingPhase 2
Combination of Novel Therapies for CKD Comorbid Depression
Combination of Novel Therapies for CKD Comorbid Depression (CONCORD)
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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% of CKD patients and independently associated with progression to End-Stage Kidney Disease, hospitalization, and death. Depression is also associated with lower quality of life (QOL), fatigue, poor sleep, and non-adherence to diet and medications. However, evidence for efficacy and tolerability of commonly-used antidepressant medications or nonpharmacologic treatments are limited in CKD patients. Our group was the first to conduct a double-blind randomized controlled trial for MDD treatment in 201 patients with non-dialysis CKD, and showed that sertraline, a commonly used selective serotonin reuptake inhibitor (SSRI), was no more efficacious than placebo for improving depressive symptoms. It becomes imperative to test novel strategies to treat MDD in CKD. We propose to compare with a control group, the efficacy and tolerability of two novel treatment strategies - (1) Behavioral Activation Teletherapy (BAT) for 16 weeks, with the addition of bupropion, a non-SSRI antidepressant, at 8 weeks for patients whose depression has not remitted (non-remitters); and (2) bupropion for 16 weeks, with the addition of BAT at 8 weeks for non-remitters. In Aim 1, we will investigate the efficacy and tolerability of these 2 strategies vs. control for improvement in a primary endpoint of depressive symptoms in 201 patients (67 per group) with CKD stages 3b-5 and MDD at 2 sites, randomized 1:1:1 to either strategy or a control group of Clinical Management plus placebo. We hypothesize that either approach vs. control will result in a minimal clinically important difference of 2 points improvement in depressive symptoms, as ascertained blindly by the Quick Inventory of Depressive Symptomatology. In Aim 2 we will investigate the efficacy and tolerability of 8 weeks of (1) single-blind BAT plus placebo or (2) double-blind bupropion plus Clinical Management vs. control for improvement in depressive symptoms. In Aim 3, we will compare the efficacy of these 2 treatments strategies vs. control for improvement in CKD patient-centered outcomes including a. adherence to medications and healthcare visits; b. fatigue; c. sleep; and d. overall functioning. A clinical trial is urgently needed to address the evidence gap that exists for MDD treatment in CKD patients.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 201 (estimated)
- First submitted
- 5 Jun 2020
- Start date
- 24 Sept 2020
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Stony Brook University
- Diseases
- Chronic kidney disease, Depression
- NCT number
- NCT04422652
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 201
- From 24 Sept 2020 to the primary completion date, 1 Sept 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Ongoing use of antidepressant medications for depression treatment
- Initiation of depression-focused psychotherapy in the 3 months prior to study entry
Other illness
- Terminal chronic obstructive pulmonary disease or cancer
- Presence of seizure disorder
- Past treatment failure on bupropion
- Present or past psychosis or Bipolar I or II disorder
- Dementia or a Mini-Mental State Examination score \<23
Lab values
- Use of medications known to cause QT prolongation on EKG
Other
- 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
- Active alcohol or substance abuse or dependence that requires acute detoxification at study entry
- Active suicidal intent
- Pregnancy, lactation, or women of childbearing potential not willing to use adequate contraception
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parkland Health and Hospital System Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| UT Southwestern and Affiliates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.