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NCT04422652 · ClinicalTrials.gov registry record · Phase 2
Combination of Novel Therapies for CKD Comorbid Depression
A Phase 2 study of Major Depressive Disorder and Chronic Kidney Diseases, sponsored by Stony Brook University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 201
- Enrollment target
- 4
- Study locations
NCT04422652 is a Phase 2 study of Major Depressive Disorder and Chronic Kidney Diseases that is actively recruiting participants, run by Stony Brook University. The registered enrollment target is 201 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT04422652, a Phase 2 study of Major Depressive Disorder and Chronic Kidney Diseases, is actively recruiting participants, sponsored by Stony Brook University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 201 participants
- Enrollment target
- 4
- Study locations
Study Summary
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. Depression is also associated with lower quality of life (QOL), fatigue, poor sleep, and non-adherence to diet and medications. However, evidence for efficacy and tolerability of commonly-used antidepressant medications or nonpharmacologic treatments are limited in CKD patients. Our group was the first to conduct a double-blind randomized controlled trial for MDD treatment in 201 patients with non-dialysis CKD, and showed that sertraline, a commonly used selective serotonin reuptake inhibitor (SSRI), was no more efficacious than placebo for improving depressive symptoms. It becomes imperative to test novel strategies to treat MDD in CKD. We propose to compare with a control group, the efficacy and tolerability of two novel treatment strategies - (1) Behavioral Activation Teletherapy (BAT) for 16 weeks, with the addition of bupropion, a non-SSRI antidepressant, at 8 weeks for patients whose depression has not remitted (non-remitters); and (2) bupropion for 16 weeks, with the addition of BAT at 8 weeks for non-remitters. In Aim 1, we will investigate the efficacy and tolerability of these 2 strategies vs. control for improvement in a primary endpoint of depressive symptoms in 201 patients (67 per group) with CKD stages 3b-5 and MDD at 2 sites, randomized 1:1:1 to either strategy or a control group of Clinical Management plus placebo. We hypothesize that either approach vs. control will result in a minimal clinically important difference of 2 points improvement in depressive symptoms, as ascertained blindly by the Quick Inventory of Depressive Symptomatology. In Aim 2 we will investigate the efficacy and tolerability of 8 weeks of (1) single-blind BAT pl
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bupropion
- BEHAVIORAL Behavioral activation therapy
- OTHER Clinical Management
Study Locations (4)
Texas
- Parkland Health and Hospital System - Dallas
- UT Southwestern and Affiliates - Dallas
New York
- Stony Brook University Medical Center - Stony Brook
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04422652
The ClinicalTrials.gov registry entry for NCT04422652 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (47% lower). The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04422652 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Texas, New York, Washington.
Frequently Asked Questions
What is clinical trial NCT04422652 about?
NCT04422652 is a clinical study titled "Combination of Novel Therapies for CKD Comorbid Depression". 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, hospita...
What is the current status of trial NCT04422652?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2020-09-24. Estimated completion is 2027-04-01.
What conditions does trial NCT04422652 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Chronic Kidney Diseases, End Stage Kidney Disease (ESRD).
What interventions are being tested in trial NCT04422652?
The interventions under investigation include: Placebo (DRUG), Bupropion (DRUG), Behavioral activation therapy (BEHAVIORAL), Clinical Management (OTHER).
Who is sponsoring clinical trial NCT04422652?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04422652 being conducted?
This trial has 4 study locations across New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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