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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.

Summary

This trial is testing two new ways to treat depression in people with chronic kidney disease. One method uses therapy sessions over the phone or internet, and the other uses a medication called bupropion. If one method doesn't work after a certain period, the other is added. The goal is to see if these treatments can improve depression and overall health in these patients. Bupropion is a second-generation antidepressant commonly used to treat depression, including in patients with chronic kidney disease.

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.

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My kidney function is low, with a GFR under 45 mL/min/1.73 m2 for at least 3 months.

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I have been diagnosed with Major Depressive Disorder.

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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:

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I am taking medication that can affect my heart's rhythm.

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I am on long-term dialysis.

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I am currently taking medication or supplements that affect serotonin levels.

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I have a seizure disorder.

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I am currently taking specific medications.

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My liver is not functioning properly, with enzyme levels more than three times the normal limit.

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I have end-stage COPD or cancer.

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I am able to understand and give informed consent.

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I have tried bupropion before, and it didn't work for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at weeks 4, 6, 8, 12, and 16.

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

0 / 13Eligibility criteria met