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NCT06124417

Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depression

Completed Phase 4 Last updated 9 November 2023
What this trial tests

Phase 4 trial testing Sertraline in Efficacy, Team in 125 participants. Completed in 29 September 2023.

Timeline
10 January 2022
Primary endpoint
25 August 2023
29 September 2023

Quick facts

Lead sponsorFirst Affiliated Hospital of Chongqing Medical University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment125
Start date10 January 2022
Primary completion25 August 2023
Estimated completion29 September 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

First Affiliated Hospital of Chongqing Medical University

Who can join

Adults 18 to 90, any sex, with Efficacy, Team or Adverse Reaction to Drug. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Depression is a common mental disorder in patients undergoing maintenance hemodialysis (MHD), which increases the risk of cardiovascular events, hospitalization rates, and mortality, but has not received enough attention from patients and medical staff. Sertraline is a selective serotonin reuptake inhibitor with fewer adverse reactions and higher safety compared to other antidepressants. This study aims to investigate the efficacy and safety of sertraline in patients undergoing MHD with depression. This study used a randomized controlled design and evaluated the depression status of the patients using the Hamilton Depression Scale (HAMD). MHD patients with comorbid depression were recruited and divided into the treatment group and the control group. The treatment group received sertraline for antidepressant therapy, while the control group did not receive any antidepressant medication. To investigate the efficacy and safety of sertraline before and after intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Safety and efficacy of sertraline in depression among adults undergoing dialysis: a systematic review and meta-analysis.
    Qammar A, Azeem B, Kumar S, Kumari M, et al · · 2024 · cited 3× · PMID 39649878 · DOI 10.1097/ms9.0000000000002677

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Other trials of Sertraline

Trials testing the same drug.

Other recruiting trials for Efficacy, Team

Currently open trials in the same condition.

Other First Affiliated Hospital of Chongqing Medical University trials

Trials by the same sponsor.

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