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

Sponsor

First Affiliated Hospital of Chongqing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT06124417

Collaborator

(none)

125

Enrollment

Location

Arms

20.6

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Efficacy, Team Adverse Reaction to Drug	Drug: Sertraline	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy and Safety of Sertraline in Maintenance Hemodialysis Patients With Depression: a Randomized Controlled Study

Actual Study Start Date :

Jan 10, 2022

Actual Primary Completion Date :

Aug 25, 2023

Actual Study Completion Date :

Sep 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group The Hamilton Rating Scale for Depression (HAMD) will be applied to assess the depressive status of all enrolled patients. This scale consists of 24 survey items, each with a score of 0-4. Patients will be assigned to the treatment group if their score was ≥8. Patients were given sertraline for antidepressant treatment in the treatment group. 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.	Drug: 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. Other Names: Conventional treatment
No Intervention: Control group Patients will be assigned to the control group if their HAMD score was <8.

Arm

Intervention/Treatment

Experimental: Treatment group

The Hamilton Rating Scale for Depression (HAMD) will be applied to assess the depressive status of all enrolled patients. This scale consists of 24 survey items, each with a score of 0-4. Patients will be assigned to the treatment group if their score was ≥8. Patients were given sertraline for antidepressant treatment in the treatment group. 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.

Drug: 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.

Other Names:

Conventional treatment

No Intervention: Control group

Patients will be assigned to the control group if their HAMD score was <8.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.