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NCT Number: NCT06124417

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

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.

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Key information

Conditions

Efficacy, Team Adverse Reaction to Drug Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Drug-Related Side Effects and Adverse Reactions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Communication, communication disorders or other psychiatric history;
  • Combined with active pulmonary tuberculosis, AIDS, severe infection patients;
  • Pregnant or lactating women;
  • Those who are taking antidepressants or other antipsychotic drugs;
  • Unable or unwilling to cooperate with the researcher.

Treatment and study plan

Sertraline

Drug

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

Primary outcomes

  1. 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.

  2. KDQOL-36 score

    Time frame: 12 weeks

    If the KDQOL-36 score increases, the quality of life is considered to be improved.

  3. Incidence of Adverse events reaction

    Time frame: 12 weeks

    Including nausea, diarrhea, constipation, anorexia, dry mouth, drowsiness, dizziness, and headache.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2023
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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