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NCT Number: NCT06840379

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

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.

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Key information

Conditions

Inflamation Behavior Behavioral Symptoms Depression Disease End Stage Renal Disease on Hemodialysis (Diagnosis) Hemodialysis Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Hospital, Multan

Multan, Punjab Province, 66000, Pakistan

About this study

After obtaining ethical approval, eligible participants were recruited from the hemodialysis unit. The study purpose, procedures, risks, and benefits were explained, and written informed consent was obtained. Participants meeting inclusion criteria underwent baseline assessments, including demographic data, medical history, HAM-D scores, and blood sampling for CRP measurement. Participants were randomly assigned to receive either sertraline or placebo using a computer-generated randomization sequence. The sertraline group initially received 25 mg/day, titrated up to a maximum of 100 mg/day over 4 weeks based on clinical response and tolerability. The placebo group received identical-looking tablets. Participants were monitored for 12 weeks, with follow-up visits every 2 weeks. Adherence, side effects, and any changes in medical status were assessed at each visit. At the end of 12 weeks, final HAM-D scores were obtained, and blood samples were collected for CRP measurement. All data were recorded on a standardized form.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Current use of antidepressants or anti-inflammatory drugs
  • Active infection or inflammatory condition
  • History of bipolar disorder or psychosis
  • Pregnancy or breastfeeding
  • Severe liver disease (Child-Pugh class C)
  • Known hypersensitivity to sertraline

Treatment and study plan

Sertraline (Oral Antidepressant)

Drug
  • 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.

Placebo

Drug
  • 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.

Primary outcomes

  1. Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks

    Time frame: Baseline and Week 12

    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.

Secondary outcomes

  1. Change in Hamilton Depression Rating Scale (HAM-D) Score from Baseline to 12 Weeks

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Depression severity will be measured using the Hamilton Depression Rating Scale (HAM-D), a validated tool for assessing depressive symptoms. HAM-D scores will be recorded at baseline, weeks 4, 8, and 12. The difference in scores between the sertraline and placebo groups will be evaluated to determine the antidepressant efficacy of sertraline.

  2. Proportion of Patients Achieving a ≥50% Reduction in HAM-D Score

    Time frame: At Week 12

    The percentage of participants achieving a ≥50% reduction in HAM-D score from baseline to week 12 will be calculated. A higher proportion in the sertraline group compared to the placebo group will indicate better treatment response.

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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