Effect of Sertraline on Depressive Symptoms in Patients With Chronic Kidney Disease Without Dialysis Dependence: The CAST Randomized Clinical Trial.
S Susan Hedayati, L Parker Gregg, Thomas Carmody...
https://pubmed.ncbi.nlm.nih.gov/29101402Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04422652
Combination of Novel Therapies for CKD Comorbid Depression (CONCORD) A Randomized Trial Comparing Behavioral Activation Teletherapy and Bupropion in Patients with Chronic Kidney Disease and Major Depressive Disorder
Led by Stony Brook University · Updated on 2025-11-28
201
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stony Brook University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new strategies to treat Major Depressive Disorder (MDD) in patients with chronic kidney disease (CKD). Depression affects about 25% of CKD patients and is linked to worse kidney outcomes, hospitalizations, and death. Current treatments like common antidepressants have limited evidence for effectiveness or safety in CKD. This study compares two novel 16-week treatment plans to see if they improve depression and related quality of life problems in CKD patients. The trial includes three groups: one receives Behavioral Activation Teletherapy (BAT) for 8 weeks plus placebo, adding bupropion for those not improving after 8 weeks; another receives bupropion medication plus clinical management, adding BAT for non-remitters; and a control group gets clinical management plus placebo for 16 weeks. Treatments are delivered via video tele-conferencing and medication, with careful monitoring. The study is randomized and blinded to compare these approaches fairly. Participants will be assessed over 16 weeks with depression symptom ratings at multiple timepoints and evaluations of medication adherence, fatigue, sleep, and overall functioning. Blood tests for inflammation markers will also be done. Researchers will track side effects and serious events to ensure safety. The study aims to understand which strategy best improves depression and patient-centered outcomes in CKD.
CONDITIONS
Brief Title
Combination of Novel Therapies for CKD Comorbid Depression
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with no upper age limit
- Diagnosed with chronic kidney disease stages 3b, 4, or 5 with estimated glomerular filtration rate below 45 mL/min/1.73 m2 for at least 3 months
- Current Major Depressive Disorder based on MINI DSM IV criteria
- Quick Inventory of Depressive Symptomatology-Self-report score of 11 or higher at enrollment and Clinician Rated score of 11 or higher at randomization
- Able to understand and sign informed consent
- Kidney transplant patients at least 6 months post-transplantation with confirmed low kidney function
You will not qualify if you...
- Unable to understand or give informed consent
- Unwilling or unable to participate or comply with study procedures
- Significant liver dysfunction with enzymes three times or more above the normal limit
- Terminal lung disease or cancer
- History of seizure disorder
- Current use of certain medications such as class I anti-arrhythmics, MAO inhibitors, tricyclic antidepressants, neuroleptics, or anticonvulsants
- Use of serotonergic drugs or supplements like triptans, tramadol, or St. John's Wort
- Medications that cause QT prolongation on EKG
- Current use of antidepressants for depression treatment
- Past treatment failure with bupropion
- Started depression-focused psychotherapy in the last 3 months
- Active alcohol or substance abuse requiring detoxification
- History or presence of psychosis or bipolar disorder
- Dementia or Mini-Mental State Examination score below 23
- Active suicidal intent
- Pregnancy, breastfeeding, or women of childbearing potential not using contraception
AI-Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 16 weeks
Participants are randomly assigned to one of three groups: Behavioral Activation Therapy plus placebo, bupropion plus clinical management, or clinical management plus placebo. Treatment lasts 16 weeks with an initial 8-week phase and possible augmentation at 8 weeks for non-remitters.
Visits at baseline and weeks 4, 6, 8, 12, and 16
Trial Site Locations
Total: 4 locations
1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8430
Not Yet Recruiting
2
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
Actively Recruiting
3
UT Southwestern and Affiliates
Dallas, Texas, United States, 75390
Actively Recruiting
4
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
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Research Team
M
Meredith McAdams, MD
A
Ana Arroyo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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