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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at weeks 4, 6, 8, 12, and 16.
Awards & highlights
CONCORD Trial 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.Check my eligibility
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.See study design
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.
CONCORD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CONCORD Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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 moreCONCORD 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
216 Previous Clinical Trials
39,770 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,534 Total Patients Enrolled
University of WashingtonOTHER
1,741 Previous Clinical Trials
1,847,565 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that can affect my heart's rhythm.I am on long-term dialysis.I am currently taking medication or supplements that affect serotonin levels.I am an adult with chronic kidney disease in stages 3b, 4, or 5 and my kidney function is below normal.You are currently struggling with alcohol or drug addiction and need immediate help to stop.I have a seizure disorder.I started therapy for depression within the last 3 months.You have memory problems or score low on a simple memory test.I am 18 years old or older.I had a kidney transplant at least 6 months ago, or 3 months ago with a low kidney function confirmed.I am willing and able to follow the study's requirements.I am currently taking specific medications.My kidney function is low, with a GFR under 45 mL/min/1.73 m2 for at least 3 months.You have had severe mental health conditions like psychosis or bipolar disorder.My liver is not functioning properly, with enzyme levels more than three times the normal limit.I have end-stage COPD or cancer.I am currently taking antidepressants for depression.I have been diagnosed with Major Depressive Disorder.I am able to understand and give informed consent.You currently have thoughts of wanting to harm yourself.I have tried bupropion before, and it didn't work for me.I have moderate to severe depression based on recent assessments.You have a score of 11 or higher on the depression symptom test at the start of the study and at randomization.
Research Study Groups:
This trial has the following groups:- Group 1: Strategy 1
- Group 2: Strategy 2
- Group 3: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Kidney Disease Patient Testimony for trial: Trial Name: NCT04422652 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit on enrollment for this experiment?
"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting participants after being initially posted on September 24th 2020 and last updated on May 27th 2022. A total of 201 patients are needed from 3 varied sites."
Answered by AI
Has Strategy 2 passed the regulatory scrutiny of the FDA?
"Our team at Power assigned Strategy 2 a score of 2 as there is prior data to suggest it is safe, but no clinical evidence that demonstrates its efficacy."
Answered by AI
Has Strategy 2 been the subject of any prior research?
"Mayo Clinic in Rochester conducted the first study of Strategy 2 back in 2017. Currently, there are 18494 completed trials and 31 active studies researching this topic, many of which take place in Seattle, Washington."
Answered by AI
Is this research endeavor currently accepting participants?
"Affirmative. The details on clinicaltrials.gov suggest that the trial is currently looking for participants, having been posted in September 2020 and updated in May 2022. Specifically, 201 people are sought from 3 medical facilities."
Answered by AI
How is Strategy 2 typically employed?
"Strategy 2 is frequently recommended to treat seasonal affective disorder, yet it may also be employed to assist people in ceasing smoking and managing other health issues."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Stony Brook University Medical Center
Parkland Health and Hospital System
University of Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried different meds. Conventional treatment for depression has never worked for me.
PatientReceived 2+ prior treatments
i suffer from depression and I have for a long time and I think I would be a good fit for the control group.
PatientReceived 1 prior treatment
I've had MDD since 2000 and was diagnosed with CKD last year. I am wanting to help try and find solutions for the illnesses.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long could it take?
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- University of Washington: < 24 hours
- Parkland Health and Hospital System: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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