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Effects of Sertraline on C-Reactive Protein Serum Levels in Hemodialysis Patients Diagnosed with Depression
Sponsor study identifier
interventional
62
1 country
1
Study Start
October 15, 2024
Actual (reported)Primary Completion
April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2024
Actual (reported)February 17, 2025
Actual (reported)February 21, 2025
Actual (reported)April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks
The mean change in CRP levels (mg/L) from baseline to 12 weeks will be assessed using high-sensitivity C-reactive protein (hs-CRP) assay. Blood samples will be collected before dialysis sessions at baseline and after 12 weeks of treatment. The difference in CRP levels between the sertraline and placebo groups will be analyzed to determine the anti-inflammatory effect of sertraline in hemodialysis patients with depression.
Baseline and Week 12
Change in Hamilton Depression Rating Scale (HAM-D) Score from Baseline to 12 Weeks
Baseline, Week 4, Week 8, and Week 12
Proportion of Patients Achieving a ≥50% Reduction in HAM-D Score
Participants in this group will receive oral sertraline, starting at 25 mg/day, with titration up to 100 mg/day based on clinical response and tolerability over the 12-week study period.
Participants in this group will receive an identical placebo tablet orally, following the same dosing schedule as the sertraline group for 12 weeks.
* 25 mg/day sertraline, titrated up to 100 mg/day based on clinical response and tolerability. * Administered orally once daily for 12 weeks. * Used to assess its effects on C-reactive protein (CRP) levels and depressive symptoms in hemodialysis patients.
* Identical placebo tablet administered orally once daily for 12 weeks, following the same dosing schedule as the sertraline group. * Used to compare the effects of sertraline vs. placebo on CRP levels and depression severity in hemodialysis patients.
Nishtar Hospital, Multan
Multan, Punjab Province, 66000, Pakistan
Muhammad Irfan Jamil
Lahore General Hospital, Lahore
62 participants (actual enrollment reported by the registry).
First Submitted
February 17, 2025
First Posted
February 21, 2025
Study Start
October 15, 2024
Actual (reported)At Week 12
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Primary Completion
April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 4, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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