Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Shanghai Mental Health Center1 个研究点分布在 1 个国家目标入组 450 人开始时间: 2022年11月1日最近更新: 2022年10月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Shanghai Mental Health Center
入组人数: 450
试验地点: 1
主要终点: the change of the HAMD-17 score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to explore the efficacy, safety and long-term effects of common and available non-invasive neuromodulation techniques in the treatment of depression, and to provide a data basis for the establishment of individualized treatment and efficacy prediction models. 450 patients will be enrolled and randomly assigned to five different treatments. Psychopathological assessment will be performed in both acute and maintenance phases of treatment with the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Patient Health Questionaire-9, the Sheehan Disability Scale, the Vascular Quality of Life-6 Questionnaire respectively.

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 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Meet the DSM-IV "major Depressive Episode" diagnostic criteria and are currently in the depressive episode (MDE) stage;
•The 17-item Hamilton Depression Scale (HAMD-17) score was > 17, and the HAMD-17 item 1 (depression) score was ≥2;
•Failure to respond adequately to at least one of the new antidepressants (including a HAMD-17 reduction rate of less than 50% and an intolerant drug side effect);
•Junior high school education or above, with sufficient audio-visual understanding of the research content, and signed the informed consent;
•If drug therapy is used at the same time, the medication regimen should remain unchanged at least 4 weeks before the follow-up group, and continue to remain unchanged during the neurological intervention in the acute phase;
•Right-handed.

排除标准

•Schizophrenia, or psychotic symptoms unrelated to depression, bipolar disorder, eating disorder, etc.;Personality disorders and mental retardation;Patients with depression caused by physical diseases;
•Suffering from the following serious diseases:History of brain injury or cerebrovascular accident, narrow-angle glaucoma, epilepsy, myocardial infarction, unstable angina pectoris, congestive heart failure, severe cirrhosis, acute and chronic renal failure, severe diabetes, aplastic anemia,Moderate to severe malnutrition and other serious neurological, heart, liver, kidney, endocrine, blood system and other physical diseases or diseases that may interfere with the study (abnormal index is more than 2 times the normal value);
•Patients with metal implants or electronic instruments (such as embedded intracranial electrodes, cochlea, medical pump, etc.), photosensitive dermatitis and other skin diseases or other contraindications in the body;
•Intracranial mass, cerebral infarction, increased intracranial pressure, or other active central nervous system disease, including epilepsy;Dementia, delirium, memory loss or other cognitive disorders;Brain trauma that increases the risk of seizures;
•Severe drug allergic reaction;
•Pregnant, lactating or planning to become pregnant;
•Substance abuse (excluding caffeine and nicotine) in the past 3 months;
•Received rTMS, tDCS, tACS, light therapy, ECT, MST, DBS therapy in the past 3 months;
•Serious suicide attempt (hamD-17 item 3 "suicide" score ≥3);
•Refuse to sign the informed consent.