Combination of Novel Therapies for CKD Comorbid Depression

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Stony Brook University
Study ID
NCT04422652
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupropion — DRUG
    Bupropion is an anti-depressant medication.
  • Behavioral activation therapy — BEHAVIORAL
    Brief behavioral activation treatments administered via video tele-conferencing.
  • Placebo — DRUG
    Double-blind placebo.
  • Clinical Management — OTHER
    Clinical management will serve as the attention control for the Behavioral Activation Therapy intervention.

Study Details

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 plus placebo or (2) double-blind bupropion plus Clinical Management vs. control for improvement in depressive symptoms. In Aim 3, we will compare the efficacy of these 2 treatments strategies vs. control for improvement in CKD patient-centered outcomes including a. adherence to medications and healthcare visits; b. fatigue; c. sleep; and d. overall functioning. A clinical trial is urgently needed to address the evidence gap that exists for MDD treatment in CKD patients.

Key Dates

Start date
Sep 24, 2020
Status verified
Nov 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
201 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Strategy 1
    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.
  • Active Comparator: Strategy 2
    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.
  • Placebo Comparator: Control
    Control: Clinical management attention control plus placebo for 16 weeks

Primary Outcome Measure

Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C) [ Time Frame: Assessed at baseline and weeks 4, 6, 8, 12, and 16 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Stony Brook University Medical CenterStony BrookNew York11794-8430-
Parkland Health and Hospital SystemDallasTexas75235-
UT Southwestern and AffiliatesDallasTexas75390-
University of WashingtonSeattleWashington98195-

Find similar trials in Stony Brook, NY

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Stony Brook University Medical Center· Stony Brook, NYParkland Health and Hospital System· Dallas, TXUT Southwestern and Affiliates· Dallas, TXUniversity of Washington· Seattle, WA

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