The Efficacy and Safety of Sertraline in Maintenance Hemodialysis Patients With Depression: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- KDQOL-36 score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sertraline (Drug)
结局指标
主要结局
KDQOL-36 score
时间窗: 12 weeks
If the KDQOL-36 score increases, the quality of life is considered to be improved.
HAMD score
时间窗: 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.
Incidence of Adverse events reaction
时间窗: 12 weeks
Including nausea, diarrhea, constipation, anorexia, dry mouth, drowsiness, dizziness, and headache.
次要结局
未报告次要终点
研究者
Yunfeng Xia
Clinical Professor
First Affiliated Hospital of Chongqing Medical University