| Outcome Measures: |
Primary: Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C), Assess the change from baseline in the QIDS-C total score in each of the intervention arms vs. the control arm. The score on the QIDS-C ranges from 0-27, with higher scores indicating more severe depressive symptoms., Assessed at baseline and weeks 4, 6, 8, 12, and 16 | Secondary: Serious adverse events, Pre-specified serious adverse events include death, hospitalization, renal replacement therapy (dialysis or kidney transplantation), and acute suicidal intent., Assessed at weeks 4, 6, 8, 12, and 16.|Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C), Assess the change from baseline in the QIDS-C total score in each of the intervention arms vs. the control arm during the first 8 weeks of the study when participants in the treatment arms will be receiving monotherapy with BAT or bupropion., Assessed at baseline and weeks 4, 6, and 8.|Serious adverse events with monotherapy, Pre-specified serious adverse events include death, hospitalization, renal replacement therapy (dialysis or kidney transplantation), and acute suicidal intent during the first 8 weeks of the study., Assessed at weeks 4, 6, and 8.|Quick Inventory of Depressive Symptomatology-Clinician Rated scale (QIDS-C), Assess the change from baseline in the QIDS-C total score in each of the intervention arms vs. the control arm during the second 8 weeks of the study when participants who did not respond to the treatment arms will be receiving combination therapy with BAT and bupropion., Assessed at weeks 8, 12, and 16.|High sensitivity C-reactive protein, Change from baseline to Week 8 in the plasma level of high sensitivity C-reactive protein (hsCRP) in the intervention groups vs. control., Assessed at baseline and week 8|Adherence to medications by Pill Count, The proportion of participants in each arm that are adherent to antidepressant medications (or placebo, prescribed in the setting of the clinical trial). Adherence will be defined as 80% or greater of study drug taken., Assessed at weeks 4, 8, 12, and 16.|Fatigue assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale, Change from baseline in the FACIT-F scale in the intervention groups vs. control. The FACIT has 13 items, each on a Likert scale, with a score range of 0-52, and higher scores indicating a lower level of fatigue., Assessed at baseline and weeks 4, 8, 12, and 16|Sleep assessed by the Insomnia Severity Index (ISI), Change from baseline in the Insomnia Severity Index (ISI) in the intervention groups vs. control. The ISI has 7 items that measure insomnia severity, with higher scores indicating more severe insomnia., Assessed at baseline and weeks 4, 8, 12, and 16|Overall functioning assessed by the Sheehan Disability Scale (SDS), Change from baseline in the SDS in the intervention groups vs. control groups. The SDS assesses functional impairment in 3 domains: work, social life, and family, each evaluated on a 10-point visual analog scale, which are summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired)., Assessed at baseline and weeks 4, 8, 12, and 16
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| Locations: |
Stony Brook University Medical Center, Stony Brook, New York, 11794-8430, United States|Parkland Health and Hospital System, Dallas, Texas, 75235, United States|UT Southwestern and Affiliates, Dallas, Texas, 75390, United States|University of Washington, Seattle, Washington, 98195, United States
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