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

NCT ID: NCT06840379

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-04-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sertraline (Oral Antidepressant)

Intervention Type: 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 Group

Participants in this group will receive an identical placebo tablet orally, following the same dosing schedule as the sertraline group for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nishtar Medical University

OTHER

Sponsor Role: lead

Responsible Party

Amra Batool

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Irfan Jamil

Role: PRINCIPAL_INVESTIGATOR

Lahore General Hospital, Lahore

Locations

Nishtar Hospital, Multan

Multan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

NishtarMU3

Identifier Type: -

Identifier Source: org_study_id