Effects of Sertraline on C-Reactive Protein Serum Levels in Hemodialysis Patients Diagnosed with Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sertraline (Oral Antidepressant) (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks
时间窗: 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.
次要结局
- Change in Hamilton Depression Rating Scale (HAM-D) Score from Baseline to 12 Weeks(Baseline, Week 4, Week 8, and Week 12)
- Proportion of Patients Achieving a ≥50% Reduction in HAM-D Score(At Week 12)
研究者
Amra Batool
Principal Investigator
Nishtar Medical University