Combining new therapies to treat depression in chronic kidney disease patients

Combination of Novel Therapies for CKD Comorbid Depression (CONCORD)

This study is testing if combining a therapy called behavioral activation with a placebo or a medication called bupropion can help people with chronic kidney disease and depression feel better over 16 weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stony Brook University (Academic / other)
• Locations: 4 sites (Stony Brook, New York and 3 other locations)
• Trial ID: NCT04422652 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether treating Major Depressive Disorder (MDD) can improve outcomes for patients with chronic kidney disease (CKD). It will compare the efficacy and tolerability of two treatment strategies over 16 weeks against a control group. The first strategy involves behavioral activation therapy (BAT) combined with placebo, while the second strategy uses bupropion with clinical management. The study will also explore the impact of remote therapy access on treatment efficacy and will include patients with non-dialysis stages 3b-5 CKD and MDD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-dialysis stages 3b-5 CKD and a current diagnosis of Major Depressive Disorder.

Not a fit: Patients who do not have chronic kidney disease or those with mild depressive symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mental health and overall outcomes for patients suffering from both CKD and depression.

How similar studies have performed: While previous studies have shown limited efficacy of traditional antidepressants in CKD patients, this approach of combining novel therapies is relatively novel and untested.

Eligibility criteria

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

Where this trial is running

Stony Brook, New York and 3 other locations

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

Study contacts

• Principal investigator: Susan Hedayati, MD — Stony Brook University
• Study coordinator: Meredith McAdams, MD

Conditions Chronic Kidney Diseases; Major Depressive Disorder; End Stage Kidney Disease