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

Adverse Reaction to Drug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06124417
• Other study ID #: The First Chongqing MU
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2022
• Est. completion date: September 29, 2023

Study information

• Verified date: November 2023
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 29, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Depression
• Drug-Related Side Effects and Adverse Reactions

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD score	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.	12 weeks
Primary	KDQOL-36 score	If the KDQOL-36 score increases, the quality of life is considered to be improved.	12 weeks
Primary	Incidence of Adverse events reaction	Including nausea, diarrhea, constipation, anorexia, dry mouth, drowsiness, dizziness, and headache.	12 weeks