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New hope for kidney patients battling depression: study tests two novel therapies

NCT ID NCT04422652

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 201 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Parkland Health and Hospital System

    Dallas, Texas, 75235, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-8430, United States

  • UT Southwestern and Affiliates

    Dallas, Texas, 75390, United States

  • University of Washington

    Seattle, Washington, 98195, United States

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