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NCT06840379Active, not recruiting

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

Effects of Sertraline on C-Reactive Protein Serum Levels in Hemodialysis Patients Diagnosed with Depression

Source: ClinicalTrials.gov · Last updated 4 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
62 (actual)
First submitted
17 Feb 2025
Start date
15 Oct 2024
Primary completion date
15 Apr 2025
Lead sponsor
Nishtar Medical University
NCT number
NCT06840379

What you commit to

  • Study type: Interventional
  • Participants enrolled: 62
  • From 15 Oct 2024 to the primary completion date, 15 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of antidepressants or anti-inflammatory drugs

Other illness

  • Active infection or inflammatory condition
  • History of bipolar disorder or psychosis
  • Severe liver disease (Child-Pugh class C)
  • Known hypersensitivity to sertraline

Other

  • Pregnancy or breastfeeding

Who the study is looking for

  • Adults aged 18-65 years
  • On maintenance hemodialysis for at least 3 months
  • Diagnosed with depression as per operational definition
  • Stable on current medications for at least 4 weeks

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nishtar Hospital Multan
Coordinator of this site? Confirm its status
MultanPakistanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.