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End Stage Kidney Disease (ESRD) / Chronic Kidney Diseases / Major Depressive Disorder · Phase 2 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 trial comparing two novel combination treatment strategies—behavioral activation teletherapy (BAT) plus bupropion versus bupropion plus BAT—against clinical management with placebo for major depressive disorder in chronic kidney disease patients. No results are yet available in this registry record; the study aims to test whether either strategy produces a clinically important 2-point improvement in depressive symptoms on the QIDS-C.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Chronic Kidney Diseases, Major Depressive Disorder, End Stage Kidney Disease (ESRD); age from 18 Years. Intervention: Strategy 1; Strategy 2. Compared with: Control — Placebo Comparator. n = 201. 4 sites: United States.
This is a planned Phase 2 trial comparing two novel combination treatment strategies—behavioral activation teletherapy (BAT) plus bupropion versus bupropion plus BAT—against clinical management with placebo for major depressive disorder in chronic kidney disease patients. No results are yet available in this registry record; the study aims to test whether either strategy produces a clinically important 2-point improvement in depressive symptoms on the QIDS-C.
This is a registry record; no results, efficacy data, or safety outcomes are reported
This trial addresses a critical evidence gap: prior work showed sertraline was no more efficacious than placebo in CKD patients with depression, and this study tests whether novel sequential or combined approaches (BAT + bupropion or vice versa) can improve outcomes. Results—when available—may reshape depression treatment in CKD and inform adherence to medications and quality of life.
This is a Phase 2 interventional trial registration with no results reported; the study is active but not yet recruiting or closed with outcomes, making it early-stage evidence.
As stated by the source record.
Quoted from the source exactly as published.
This trial addresses a critical evidence gap: prior work showed sertraline was no more efficacious than placebo in CKD patients with depression, and this study tests whether novel sequential or combined approaches (BAT + bupropion or vice versa) can improve outcomes. Results—when available—may reshape depression treatment in CKD and inform adherence to medications and quality of life.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04422652). This is a study registration, not published results. Lead sponsor: Stony Brook University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 201 participants (ESTIMATED). Conditions: Chronic Kidney Diseases, Major Depressive Disorder, End Stage Kidney Disease (ESRD). Interventions: DRUG: Bupropion; BEHAVIORAL: Behavioral activation therapy; DRUG: Placebo; OTHER: Clinical Management. Primary outcome measures: Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C) , Assessed at baseline and weeks 4, 6, 8, 12, and 16. 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% 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.
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