Clinical trial
The Efficacy and Safety of Sertraline in Maintenance Hemodialysis Patients With Depression: a Randomized Controlled Study
Name
The First Chongqing MU
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.
Trial arms
Trial start
2022-01-10
Estimated PCD
2023-08-25
Trial end
2023-09-29
Status
Completed
Phase
Early phase I
Treatment
Sertraline
The initial dose ranged from 25 to 50 mg, taken orally once daily, and the dosage was adjusted based on the patient's response to the medication.
Arms:
Treatment group
Other names:
Conventional treatment
Size
125
Primary endpoint
HAMD score
12 weeks
KDQOL-36 score
12 weeks
Incidence of Adverse events reaction
12 weeks
Eligibility criteria
Inclusion Criteria:
1. 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;
2. Meet the CKD5 diagnostic criteria;
3. The cardiopulmonary function was relatively stable before enrollment, and the life expectancy was more than 1 year;
4. The clinical data were basically complete;
5. Consciousness, intelligence is normal, can understand the questionnaire content.
Exclusion Criteria:
1. Communication, communication disorders or other psychiatric history;
2. Combined with active pulmonary tuberculosis, AIDS, severe infection patients;
3. Pregnant or lactating women;
4. Those who are taking antidepressants or other antipsychotic drugs;
5. Unable or unwilling to cooperate with the researcher.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 125, 'type': 'ACTUAL'}}
Updated at
2023-11-09
1 organization