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Combination Therapies for Depression with Kidney Disease (CONCORD Trial)

Phase 2
Recruiting
Led By Susan Hedayati, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female adults aged 18 years or greater with presence of CKD stages 3b, 4 or non-dialysis stage 5, and estimated glomerular filtration rate (GFR) of <45 mL/min/1.73 m2 for at least 3 months
Presence of CKD stages 3b, 4 or non-dialysis stage 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.
Must not have
Use of medications known to cause QT prolongation on EKG
Receiving chronic dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at weeks 4, 6, 8, 12, and 16.
Awards & highlights

Summary

This trial is testing two novel treatment strategies for Major Depressive Disorder in patients with chronic kidney disease, compared to a control group. The trial will test the efficacy and tolerability of the treatments.

Who is the study for?
Adults aged 18+ with chronic kidney disease stages 3b-5 and a confirmed diagnosis of Major Depressive Disorder. Participants must have a specific level of depressive symptoms, be able to consent, and not be on dialysis. Exclusions include significant liver issues, certain severe diseases, seizure disorders, use of conflicting medications or supplements, substance abuse needing detoxification, psychosis or bipolar disorder history.
What is being tested?
The trial is testing the effectiveness of Behavioral Activation Teletherapy (BAT) and bupropion (a non-SSRI antidepressant) against placebo in improving depression in CKD patients. It's structured so that if there's no improvement after 8 weeks for some patients, they'll receive an additional treatment. The study aims to see if these treatments can also improve medication adherence and overall quality of life.
What are the potential side effects?
Possible side effects may include typical reactions to antidepressants like headaches, nausea, dry mouth for bupropion; behavioral therapy usually has minimal risks but might involve temporary increases in distress as one confronts difficult emotions or situations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult with chronic kidney disease in stages 3b, 4, or 5 and my kidney function is below normal.
Select...
My kidney function is low, with a GFR under 45 mL/min/1.73 m2 for at least 3 months.
Select...
I have been diagnosed with Major Depressive Disorder.
Select...
I have moderate to severe depression based on recent assessments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking medication that can affect my heart's rhythm.
Select...
I am on long-term dialysis.
Select...
I am currently taking medication or supplements that affect serotonin levels.
Select...
I have a seizure disorder.
Select...
I am currently taking specific medications.
Select...
My liver is not functioning properly, with enzyme levels more than three times the normal limit.
Select...
I have end-stage COPD or cancer.
Select...
I am able to understand and give informed consent.
Select...
I have tried bupropion before, and it didn't work for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at weeks 4, 6, 8, 12, and 16.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at weeks 4, 6, 8, 12, and 16. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adherence to medications by Pill Count
Fatigue assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale
High sensitivity C-reactive protein
+5 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Strategy 1Active Control2 Interventions
Strategy 1: Single-blind Behavioral Activation Therapy plus placebo for 8 weeks (Phase 1), augmented in non-remitters at 8 weeks with single-blind bupropion (Phase 2) for another 8 weeks.
Group II: Strategy 2Active Control2 Interventions
Strategy 2: Double-blind bupropion plus single-blind Clinical Management (CM) attention control for 8 weeks (Phase 1), augmented in non-remitters at 8 weeks with single-blind BAT (Phase 2) for another 8 weeks.
Group III: ControlPlacebo Group2 Interventions
Control: Clinical management attention control plus placebo for 16 weeks

Find a Location

Who is running the clinical trial?

Stony Brook UniversityOTHER
222 Previous Clinical Trials
41,727 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,056,061 Total Patients Enrolled
University of WashingtonOTHER
1,791 Previous Clinical Trials
1,905,305 Total Patients Enrolled

Media Library

Behavioral Activation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04422652 — Phase 2
Chronic Kidney Disease Research Study Groups: Strategy 1, Strategy 2, Control
Chronic Kidney Disease Clinical Trial 2023: Behavioral Activation Therapy Highlights & Side Effects. Trial Name: NCT04422652 — Phase 2
Behavioral Activation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04422652 — Phase 2
Chronic Kidney Disease Patient Testimony for trial: Trial Name: NCT04422652 — Phase 2
~22 spots leftby Apr 2025
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