| Trial ID: | L0688 |
| Source ID: | NCT06840379
|
| Associated Drug: |
Sertraline (Oral Antidepressant)
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| Title: |
Effect of Sertraline on Inflammation in Hemodialysis Patients with Depression: a Randomized Controlled Trial
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| Acronym: |
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| Status: |
ACTIVE_NOT_RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Inflamation|Hemodialysis|End Stage Renal Disease on Hemodialysis (Diagnosis)
|
| Interventions: |
DRUG: Sertraline (Oral Antidepressant)|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Nishtar Medical University
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
62
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-10-15
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| Completion Date: |
2025-04-15
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| Results First Posted: |
|
| Last Update Posted: |
2025-03-04
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| Locations: |
Nishtar Hospital, Multan, Multan, Punjab, 66000, Pakistan
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| URL: |
https://clinicaltrials.gov/show/NCT06840379
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