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ACTIVE NOT RECRUITING
NCT06840379
NA

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

Sponsor: Nishtar Medical University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2024-10-15

Completion Date

2025-04-15

Last Updated

2025-03-04

Healthy Volunteers

No

Interventions

DRUG

Sertraline (Oral Antidepressant)

* 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.

DRUG

Placebo

* 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.

Locations (1)

Nishtar Hospital, Multan

Multan, Punjab Province, Pakistan