Combination of Novel Therapies for CKD Comorbid Depression (CONCORD)

Official 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 pl

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 201 participants

Interventions

• DRUG: Bupropion — Bupropion is an anti-depressant medication.
• BEHAVIORAL: Behavioral activation therapy — Brief behavioral activation treatments administered via video tele-conferencing.
• DRUG: Placebo — Double-blind placebo.
• OTHER: Clinical Management — Clinical management will serve as the attention control for the Behavioral Activation Therapy intervention.

Primary Outcomes

• Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C) (Assessed at baseline and weeks 4, 6, 8, 12, and 16)

Secondary Outcomes

• Serious adverse events (Assessed at weeks 4, 6, 8, 12, and 16.)
• Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C) (Assessed at baseline and weeks 4, 6, and 8.)
• Serious adverse events with monotherapy (Assessed at weeks 4, 6, and 8.)
• Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C) (Assessed at weeks 8, 12, and 16.)
• High sensitivity C-reactive protein (Assessed at baseline and week 8)

Trial Locations

• Stony Brook University Medical Center, Stony Brook, New York, United States
• Parkland Health and Hospital System, Dallas, Texas, United States
• UT Southwestern and Affiliates, Dallas, Texas, United States
• University of Washington, Seattle, Washington, United States

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