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

NCT06124417 | Completed Phase 4

• 1 other identifier: The First Chongqing MU
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy, Team; Adverse Reaction to Drug

Keywords

Hemodialysis; Depression; Sertraline; Efficacy; Safety

Outcome Measures

Primary Outcomes (3)

• 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

• KDQOL-36 score

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

  12 weeks

• Incidence of Adverse events reaction

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

  12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Also known as: Conventional treatment

Treatment group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Yunfeng Xia, Dr.

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: January 10, 2022
• Primary Completion: August 25, 2023
• Study Completion: September 29, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CN (1)