Clinical trial NCT06124417: Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depression
Official title: The Efficacy and Safety of Sertraline in Maintenance Hemodialysis Patients With Depression: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Efficacy, Team
Adverse Reaction to Drug
Keywords: Hemodialysis
Depression
Sertraline
Efficacy
Safety
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: HAMD score
timeFrame: 12 weeks
measure: KDQOL-36 score
timeFrame: 12 weeks
measure: Incidence of Adverse events reaction
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Yunfeng Xia, Dr.
role: STUDY_DIRECTOR
References: