Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depr… (NCT06124417) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depression
China125 participantsStarted 2022-01-10
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Long-term MHD patients in the blood purification center of our hospital, older than 18 years old, maintenance dialysis for at least 3 months, 2-3 times a week, 3-4.5 hours each time;
✓. Meet the CKD5 diagnostic criteria;
✓. The cardiopulmonary function was relatively stable before enrollment, and the life expectancy was more than 1 year;
✓. The clinical data were basically complete;
✓. Consciousness, intelligence is normal, can understand the questionnaire content.
Exclusion criteria
✕. Communication, communication disorders or other psychiatric history;
✕. Combined with active pulmonary tuberculosis, AIDS, severe infection patients;
✕. Pregnant or lactating women;
✕. Those who are taking antidepressants or other antipsychotic drugs;
✕
What they're measuring
1
HAMD score
Timeframe: 12 weeks
2
KDQOL-36 score
Timeframe: 12 weeks
3
Incidence of Adverse events reaction
Timeframe: 12 weeks
Trial details
NCT IDNCT06124417
SponsorFirst Affiliated Hospital of Chongqing Medical University