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New treatment option for Chronic Kidney Diseases
Official title Combination of Novel Therapies for CKD Comorbid Depression
ClinicalTrials.gov ID: NCT04422652
What this study is testing
What is Bupropion?
Bupropion is an investigational medicine, being studied as a potential treatment for chronic kidney diseases.
Also referred to as Wellbutrin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The overall goal of the study is to determine if treatment of a Major Depressive Disorder (MDD) improves the outcomes of patients with chronic kidney disease (CKD). We showed that MDD is present in 25% of CKD patients and independently associated with progression to End-Stage Kidney Disease, hospitalization, and death.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female adults aged 18 years or greater. There will be no upper age limit.
- 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...
- Presence of a current Major Depressive Disorder (MDD) based on MINI DSM IV-based criteria
- Quick Inventory of Depressive Symptomatology-Self-report (QIDS-SR) score of ≥11 at enrollment and ≥11 on QIDS-Clinician Rated (QIDS-C) at...
- Able to understand and sign informed consent after the nature of the study has been fully explained
You likely can't join if
- Unable to understand or give informed consent.
- Unwilling or unable to participate in the protocol or comply with any of its components
- Significant hepatic dysfunction or liver enzyme abnormalities 3 times or greater than the upper limit of normal
- Terminal chronic obstructive pulmonary disease or cancer
- Presence of seizure disorder
- Current use of class I anti-arrhythmic medications (such as 1C propafenone and flecanide), pimozide, MAO inhibitors, reserpine, guanethidine...
See the full eligibility criteria
- Male or female adults aged 18 years or greater. There will be no upper age limit.
- 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...
- Presence of a current Major Depressive Disorder (MDD) based on MINI DSM IV-based criteria
- Quick Inventory of Depressive Symptomatology-Self-report (QIDS-SR) score of ≥11 at enrollment and ≥11 on QIDS-Clinician Rated (QIDS-C) at randomization.
- Able to understand and sign informed consent after the nature of the study has been fully explained
- 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)
- Unable to understand or give informed consent.
- Unwilling or unable to participate in the protocol or comply with any of its components
- Significant hepatic dysfunction or liver enzyme abnormalities 3 times or greater than the upper limit of normal
- Terminal chronic obstructive pulmonary disease or cancer
- Presence of seizure disorder
- 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...
- Use of serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.
- Use of medications known to cause QT prolongation on EKG
- Ongoing use of antidepressant medications for depression treatment
- Past treatment failure on bupropion
- Initiation of depression-focused psychotherapy in the 3 months prior to study entry
- Active alcohol or substance abuse or dependence that requires acute detoxification at study entry
- Present or past psychosis or Bipolar I or II disorder
- Dementia or a Mini-Mental State Examination score \<23
- Active suicidal intent
- Pregnancy, lactation, or women of childbearing potential not willing to use adequate contraception
The study team makes the final eligibility decision.
Where it's taking place
- Stony Brook, New York, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stony Brook, New York, United States; Dallas, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.