Adverse Reaction to Drug, Efficacy, Team
Conditions
Keywords
Hemodialysis, Depression, Sertraline, Efficacy, Safety
Brief 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.
Detailed description
The HAMD, the Medication Adherence Report Scale-5 (MARS-5), the Mini Nutritional Assessment short-form (MNA-SF) and the Kidney Disease Quality of Life-36 (KDQOL-36) scales were used to evaluate changes in depression status, quality of life, medication adherence and nutritional status before and after the intervention. Clinical and laboratory indicators were collected before and after the intervention. Adverse reactions during the intervention were also recorded. 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. In the control group, no antidepressant treatment was given.
Interventions
DRUGSertraline
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.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAMD score | 12 weeks | If there is no decrease in HAMD score after treatment, it is considered ineffective. If the score decreases but remains ≥8, it is considered partial improvement. If the score decreases to below 8, it is considered complete remission. |
| KDQOL-36 score | 12 weeks | If the KDQOL-36 score increases, the quality of life is considered to be improved. |
| Incidence of Adverse events reaction | 12 weeks | Including nausea, diarrhea, constipation, anorexia, dry mouth, drowsiness, dizziness, and headache. |
Countries
China
Outcome results
None listed