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

November 8, 2023 updated by: Yunfeng Xia, First Affiliated Hospital of Chongqing Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Investigators

  • Study Director: Yunfeng Xia, Dr., First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

August 25, 2023

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The First Chongqing MU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adverse Reaction to Drug

Clinical Trials on Sertraline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe