MedTrace Logo

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

NCT06840379 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Inflamation
  • Hemodialysis
  • End Stage Renal Disease on Hemodialysis (Diagnosis)

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.

Sponsors & Collaborators

  • Nishtar Medical University

    lead OTHER

Principal Investigators

  • Muhammad Irfan Jamil · Lahore General Hospital, Lahore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840379 on ClinicalTrials.gov