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Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease
This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.
This is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 Chronic Kidney Disease and Major Depressive Episode. Subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. The primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C-16) score. Secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Start Date
February 8, 2010
Primary Completion Date
November 23, 2016
Completion Date
November 1, 2017
Last Updated
March 9, 2018
201
ACTUAL participants
Sertraline
DRUG
placebo
DRUG
Lead Sponsor
VA Office of Research and Development
Collaborators
NCT07360600
NCT07241390
Data Source & Attribution
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