The First Affiliated Hospital of Xi'an Jiaotong University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Scores of Hamilton Depression Scale
研究概览
简要总结
The patients with depression were observed and followed up to evaluate the changes of symptoms and cognitive function in patients with depression at different time points before and after drug treatment. At the same time, immunometabolism indicators in serum, urine and stool were detected to screen out immunoinflammatory markers related to cognitive function and treatment response in patients with depression, hoping to provide a new strategy for optimal treatment of depression.
详细描述
- Participants were included according to the inclusion and exclusion criteria, and demographic data of depressed patients and healthy controls were recorded, including age, sex, ethnicity, occupation, etc. Subjects in the depression group were treated with antidepressants (as recommended by the guidelines) and were followed up baseline, 2 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment, respectively. At each follow-up point, symptoms were assessed using Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Depression Screening Scale (PHQ-9) and Generalized Anxiety Scale (GAD-7), and cognitive function was assessed using Thinc-it at three follow-up points: baseline, 12 weeks after treatment, and 24 weeks after treatment. General data were compared between patients with depression and healthy controls at baseline.
- The depression group was followed up. Serum and fecal of patients with depression were collected at 5 follow-up points at baseline, 2 weeks, 8 weeks, 12weeks and 24 weeks after treatment, and serum metabolic indexes and fecal metagenome were detected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old, male or female;
- •Meet the diagnostic criteria for depression in the International Classification of Diseases-10 (ICD-10), and the Hamilton Depression Scale (HAMD) score ≥18 points;
- •Junior high school education and above, can cooperate with the completion of relevant scales and sample collection;
- •did not receive antidepressant therapy at admission or took medication for less than 14 days; And the duration of drug withdrawal ≥3 months;
- •No history of infection and taking hormones, antibiotics or anti-inflammatory drugs in the past 1 month;
- •History of physical diseases such as centerless, liver, kidney and gastrointestinal tract, active infection, active or chronic inflammation, autoimmune diseases, etc.
排除标准
- •Pregnant and lactating women;
- •Clinically significant or unstable medical conditions, including congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases;
- •Patients with acute or chronic infection, taking anti-inflammatory drugs, cortisol hormones, and receiving antibiotics for 3 consecutive days in the past 1 month;
- •Patients with neuropsychiatric diseases other than depression.
结局指标
主要结局
Scores of Hamilton Depression Scale
时间窗: baseline、2weeks、8weeks、12weeks、24weeks
Using to assess depressive symptoms. With higher scores associated with more severe depression symptoms. Total scores \<7 is normal; Mild depression with total scores of 7～17; Moderate depression with total scores of 18～24; Total scores \>24 for severe depression.
Patient Health Questionnaire-9
时间窗: baseline、2weeks、8weeks、12weeks、24weeks
Using to assess depression symptoms, scores range from 0～27, With higher scores associated with more severe depression symptoms. Total scores 0～4 indicates no depression; Total scores 5～9 indicates mild depression; Total scores 10～14 indicates moderate depression; Total scores 15～19 indicate moderate to severe depression; Total scores 20～27 indicates major depression.
Scores of Hamilton Anxiety Scale
时间窗: baseline、2weeks、8weeks、12weeks、24weeks
Using to assess anxiety symptoms. With higher scores associated with more severe anxiety symptoms. Total scores\< 7 indicates no anxiety; Total scores≥7 indicates possible anxiety; Total scores≥14 indicates anxiety; Total scores≥21 indicates obvious anxiety; Total scores≥29 points indicates serious anxiety.
Generalized self-rating anxiety Scale
时间窗: baseline、2weeks、8weeks、12weeks、24weeks
Using to assess anxiety symptoms, scores range from 0～21. With higher scores associated with more severe anxiety symptoms. Total scores 5～9 indicates mild anxiety; Total scores 10～14 scores indicate moderate anxiety; Total scores 15～21 scores indicate severe anxiety.
次要结局
- Pittsburgh Sleep Quality Index(baseline、2weeks、8weeks、12weeks、24weeks)
- Thinc-it cognitive function test(basline、12weeks、24weeks)
- Gastrointestinal function scale(baseline、2weeks、8weeks、12weeks、24weeks)
- Sheehan Disability Scale(basline、12weeks、24weeks)