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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemodialysis; End Stage Renal Disease on Hemodialysis (Diagnosis); Inflamation
• Intervention / Treatment: Drug: Sertraline (Oral Antidepressant); Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Multan, Punjab, Pakistan, 66000
      • Nishtar Hospital, Multan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sertraline Group; 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.	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.
Placebo Comparator: Placebo Group; Participants in this group will receive an identical placebo tablet orally, following the same dosing schedule as the sertraline group for 12 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hamilton Depression Rating Scale (HAM-D) Score from Baseline to 12 Weeks	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.	Baseline, Week 4, Week 8, and Week 12
Proportion of Patients Achieving a ≥50% Reduction in HAM-D Score	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.	At Week 12

Collaborators and Investigators

• Sponsor: Nishtar Medical University
• Investigators: Principal Investigator: Muhammad Irfan Jamil, Lahore General Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Depression in Chronic Kidney Disease; Hemodialysis and Mental Health; Sertraline and Inflammation; C-Reactive Protein and Depression; Psychiatric Comorbidities in ESRD
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Behavioral Symptoms; Mood Disorders; Renal Insufficiency; Renal Insufficiency, Chronic; Depression; Depressive Disorder; Kidney Failure, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Antidepressive Agents; Sertraline
• Other Study ID Numbers: NishtarMU3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No