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Effect of Sertraline on Inflammation in Hemodialysis Patients with Depression: a Randomized Controlled Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 4, 2025 (before its estimated April 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Study description expanded, about 145 wordsv2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Depression is a common mental health condition among patients undergoing hemodialysis and is associated with a lower quality of life, poor treatment adherence, and worse overall health outcomes. Chronic inflammation, as measured by elevated C-reactive protein (CRP) levels, is frequently seen in these patients and contributes to an increased risk of cardiovascular disease, the leading cause of death in this population. Sertraline, a widely used antidepressant, is effective in treating depression in hemodialysis patients and has been suggested to have anti-inflammatory properties. This study aims to evaluate whether sertraline can reduce inflammation, as measured by CRP levels, in hemodialysis patients diagnosed with depression. This research is a randomized, double-blind, placebo-controlled trial conducted at Nishtar Hospital, Multan. A total of 62 adult hemodialysis patients with depression will be enrolled and randomly assigned to receive either sertraline or a placebo for 12 weeks. Depression severity will be assessed using the Hamilton Depression Rating Scale (HAM-D), a widely used tool for measuring the severity of depressive symptoms. HAM-D scores will be recorded at baseline, at weeks 4, 8, and 12 to evaluate changes in depressive symptoms over time. CRP levels will also be measured at baseline and after 12 weeks to determine whether sertraline reduces systemic inflammation in these patients. The hypothesis of this study is that sertraline treatment will significantly lower CRP levels compared to a placebo, potentially providing dual benefits-improving mood and reducing inflammation-related health risks in hemodialysis patients. The findings of this study could help improve treatment strategies for depression and inflammation in individuals undergoing long-term dialysis.
Trial Details
NCT Number NCT06840379
Lead Sponsor Nishtar Medical University
Conditions
(from sponsor)
Inflamation, Hemodialysis, End Stage Renal Disease on Hemodialysis (Diagnosis)
Related terms Depression, Disease, Inflammation, Psychological Well-Being
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov