Clinical trial NCT06840379: Effect of Sertraline on Inflammation in Hemodialysis Patients with Depression: a Randomized Controlled Trial
Official title: Effects of Sertraline on C-Reactive Protein Serum Levels in Hemodialysis Patients Diagnosed with Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflamation
Hemodialysis
End Stage Renal Disease on Hemodialysis (Diagnosis)
Keywords: Depression in Chronic Kidney Disease
Hemodialysis and Mental Health
Sertraline and Inflammation
C-Reactive Protein and Depression
Psychiatric Comorbidities in ESRD
Lead sponsor: Nishtar Medical University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Hamilton Depression Rating Scale (HAM-D) Score from Baseline to 12 Weeks
timeFrame: Baseline, Week 4, Week 8, and Week 12
measure: Proportion of Patients Achieving a ≥50% Reduction in HAM-D Score
timeFrame: At Week 12
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Hospital, Multan
state: Punjab
Study officials:
affiliation: Lahore General Hospital, Lahore
name: Muhammad Irfan Jamil
role: PRINCIPAL_INVESTIGATOR
References: