Association of Peripheral Immune Cells With Antidepressant Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change of HAMD-17 (Hamilton Depression Rating Scale) total score
研究概览
简要总结
The purpose of this observational study is discovering potential biomarkers to predict antidepressant treatment response in patients with major depressive disorder (MDD) while comparing the transcriptomic changes between patients with MDD and healthy controls as well as before and after antidepressant treatment.
Eligible patients will be assessed at Week 1, Week 2, Week 4 and Week 8 while healthy normal volunteers will only be evaluated at baseline. Assessments will include the following: an interview about mental and physical health, a physical examination including drawing of venous blood samples and several psychiatric rating scales.
详细描述
This study is focusing on evaluating the peripheral immune system of major depressive disorder (MDD) and the impact of antidepressants treatment. Single-cell RNA sequencing and single-cell VDJ sequencing will be performed on peripheral blood mononuclear cells to collect transcriptome information and immune repertoire of peripheral blood in patients with MDD. Bulk RNA sequencing and flow cytometry will be used to validate the clinical value of results.
This is a biomarker study (antidepressants); treatment will be carried out according to physicians' orders.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years old, regardless of gender;
- •The subject is an outpatient/inpatient and meets DSM-5 diagnostic criteria of current or past major depressive disorder;
- •SSRIs or SNRIs monotherapy;
- •HAMD-17 total score ≥ 18 at baseline;
- •The subject can read and write and is capable of giving informed consent.
排除标准
- •Patients with mental illness other than MDD;
- •Patients with liver and kidney diseases, cardiovascular system diseases, cancer, diabetes, thyroid diseases or other serious or unstable conditions;
- •Previous organic brain disease, traumatic brain injury or other diseases that can cause structural brain changes;
- •Serious abnormalities indicated by laboratory tests or electrocardiograms;
- •Alcohol or drug addiction;
- •Suffering from systemic lupus erythematosus, multiple sclerosis or other autoimmune diseases;
- •Patients who are taking drugs that directly impact on the immune system such as anti-inflammatory drugs or immunosuppressants;
- •Patients who have taken antidepressants or other antipsychotics within 2 weeks before enrollment;
- •Patients who have received MECT or systematic psychotherapy within 3 months before enrollment;
- •Patients at high risk of suicide, or reporting a HAMD-17 item 3 (suicide item) score >3 at baseline;
- •Subjects who are pregnant or lactating;
- •Other conditions that are considered not suitable for participating in the research.
结局指标
主要结局
Change of HAMD-17 (Hamilton Depression Rating Scale) total score
时间窗: From baseline to Week 8
The overall score of HAMD-17 (Hamilton Depression Rating Scale) is 68 points. Primary outcome measures the change of HAMD-17 total score between baseline and week 8. Larger reduction in HAMD-17 represents better antidepressant treatment response.
次要结局
- MADRS Remission rate measured by MADRS (Montgomery-Åsberg depression rating scale)(From baseline to Week 8)
- Effective rate measured by HAMD-17 (Hamilton Depression Rating Scale)(From baseline to Week 8)
- Remission rate measured by HAMD-17 (Hamilton Depression Rating Scale)(From baseline to Week 8)
- MADRS Effective rate measured by MADRS (Montgomery-Åsberg depression rating scale)(From baseline to Week 8)
研究者
LI, Huafang
Principal Investigator
Shanghai Mental Health Center