Randomized Controlled Study on the Effect of Pharmacogenomics on Individualized Precise Treatment of Patients with Depression
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Pharmacogenomics
- 发起方
- Tongji University
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 17-items Hamilton Depression Scale
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
Based on pharmacogenomics analysis technology, this topic explored its impact on individualized precise treatment of patients with depression through randomized controlled trials. The study subjects were depression patients from the mental health research center affiliated to Tongji University. The sample size was estimated by PASS 21.0.3 software. The sample size of the intervention group and the control group was 60 cases each, and SPSS 25.0 software was used for random sampling. The intervention group completed the pharmacogenomic analysis of antidepressants before using them, and selected appropriate antidepressants according to the characteristics of pharmacokinetics and pharmacodynamics of individual patients, while the control group was administered according to routine treatment. 17 items Hamilton Compression Scale (HAMD-17), Hamilton Anxiety Scale (HAMA), Dimensional Anhedonia Rating Scale (DARS), Pittsburgh sleep quality index (PSQI), Antidepressant Side Effect Checklist (ASEC), Short form 36 item health survey questionnaire (SF-36) (PDQ) assessment. R Project 4.1.1 software was used for statistical analysis of data, PLink v1.07 and Haploview software were used for association analysis of whole genome and drug efficacy and adverse reactions. To explore the difference between the reduction rate of drug efficacy and adverse reactions in patients with depression after pharmacogenomics intervention and conventional treatment. At the same time, we verified and found the gene loci related to the efficacy and adverse reactions of antidepressants in the East Asian population.
研究者
Jie Tong
Clinical Professor
Tongji University
入排标准
入选标准
- •Both biological parents are Chinese nationals;
- •Conform to the diagnostic criteria of depression in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •The total score of 17 items of Hamilton Depression Scale (HAMD-17) is ≥ 17;
- •Never used relevant antidepressant drugs;
- •Have a certain visual and auditory discrimination, and have no understanding obstacle;
- •Be able to independently complete the scale measurement;
- •Education level above primary school;
- •Obtain the written informed consent of the patient. If the patient is incapacitated during the onset of the disease, the written informed consent of the legal guardian is required.
排除标准
- •Patients with schizophrenia, schizoaffective disorder, bipolar affective disorder, mental retardation, generalized developmental disorder, delirium, dementia, cognitive dysfunction, alcohol dependence and other diagnoses;
- •Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, brain injury, cerebral ischemia or hemorrhage;
- •Patients with narrow angle glaucoma;
- •History of epilepsy and febrile convulsion;
- •Those who have taken drugs in the past;
- •Syphilis specific antibody and AIDS antibody are positive;
- •Those who received MECT or rTMS and other neuromodulation therapy one month before enrollment;
- •The risk assessment indicates that there is a serious suicide attempt or excitement;
- •Laboratory examination indicates that liver function and renal function are impaired;
- •Pregnant or lactating women, or those who plan to have a pregnancy in the near future;
结局指标
主要结局
17-items Hamilton Depression Scale
时间窗: Week 32
Evaluate the severity and treatment effect of the patient's depression within one week.
Perceived deficits questionnaire
时间窗: Week 32
Assess the patient's subjective cognitive function within one week.
Genomic analysis of antidepressants
时间窗: Baseline
Using PCR gene chip detection method and Asian Screening Array (ASA) chip detection technology of Illumina Company, we can obtain the genetic information of polymorphic sites related to the individual differences of drug effects of subjects.
Dimensional Anhedonia Rating Scale
时间窗: Week 32
Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
Antidepressant Side-Effect Checklist
时间窗: Week 32
Evaluate the adverse reactions of patients after using antidepressants.
次要结局
- Hamilton Anxiety Scale(Week 32)
- Pittsburgh sleep quality index(Week 32)
- Short-form 36 item health survey questionnaire(Week 32)