New hope for kidney patients battling depression: study tests two novel therapies
NCT ID NCT04422652
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study aims to find better ways to treat depression in people with chronic kidney disease (CKD). About 201 adults with advanced CKD and major depression will receive either behavioral activation teletherapy plus a non-SSRI antidepressant, or the antidepressant plus teletherapy, or a placebo with clinical management. The goal is to see which approach improves mood, quality of life, and treatment adherence.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 201 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Parkland Health and Hospital System
Dallas, Texas, 75235, United States
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Stony Brook University Medical Center
Stony Brook, New York, 11794-8430, United States
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UT Southwestern and Affiliates
Dallas, Texas, 75390, United States
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University of Washington
Seattle, Washington, 98195, United States
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Other studies related to the condition(s) this trial covers.
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