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

Not Applicable

Active, not recruiting

• Conditions: Inflamation; Hemodialysis; End Stage Renal Disease on Hemodialysis (Diagnosis)
• Interventions: Drug: Sertraline (Oral Antidepressant); Drug: Placebo

• Registration Number: NCT06840379
• Lead Sponsor: Nishtar Medical University

Brief 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.

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 Timeline

• Study Start: 2024-10-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertraline Group	Sertraline (Oral Antidepressant)	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.
Placebo Group	Placebo	Participants in this group will receive an identical placebo tablet orally, following the same dosing schedule as the sertraline group for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks	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 Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale (HAM-D) Score from Baseline to 12 Weeks	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.
Proportion of Patients Achieving a ≥50% Reduction in HAM-D Score	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.

Trial Locations

Locations (1)

Nishtar Hospital, Multan; 🇵🇰 Multan, Punjab, Pakistan