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RECRUITING

NCT04422652

PHASE2

Combination of Novel Therapies for CKD Comorbid Depression

Sponsor: Stony Brook University

View on ClinicalTrials.gov

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.

Official title: Combination of Novel Therapies for CKD Comorbid Depression (CONCORD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

201

Start Date

2020-09-24

Completion Date

2027-04-01

Last Updated

2025-11-28

Healthy Volunteers

Conditions

Chronic Kidney Diseases Major Depressive Disorder End Stage Kidney Disease (ESRD)

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.

Inclusion Criteria: 1. Male or female adults aged 18 years or greater. There will be no upper age limit. 2. 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. 3. Presence of a current Major Depressive Disorder (MDD) based on MINI DSM IV-based criteria 4. Quick Inventory of Depressive Symptomatology-Self-report (QIDS-SR) score of ≥11 at enrollment and ≥11 on QIDS-Clinician Rated (QIDS-C) at randomization. 5. Able to understand and sign informed consent after the nature of the study has been fully explained 6. 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 Criteria: 1. Unable to understand or give informed consent. 2. Unwilling or unable to participate in the protocol or comply with any of its components 3. Significant hepatic dysfunction or liver enzyme abnormalities 3 times or greater than the upper limit of normal 4. Terminal chronic obstructive pulmonary disease or cancer 5. Presence of seizure disorder 6. 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 7. Use of serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort. 8. Use of medications known to cause QT prolongation on EKG 9. Ongoing use of antidepressant medications for depression treatment 10. Past treatment failure on bupropion 11. Initiation of depression-focused psychotherapy in the 3 months prior to study entry 12. Active alcohol or substance abuse or dependence that requires acute detoxification at study entry 13. Present or past psychosis or Bipolar I or II disorder 14. Dementia or a Mini-Mental State Examination score \<23 15. Active suicidal intent 16. Pregnancy, lactation, or women of childbearing potential not willing to use adequate contraception

Locations (4)

Stony Brook University Medical Center

Stony Brook, New York, United States

Parkland Health and Hospital System

Dallas, Texas, United States

UT Southwestern and Affiliates