SSRIs combined with Shugan Jieyu in the treatment of depression: a multicenter randomized, controlled, double-blind, prospective study

Shandong Mental Health Center0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

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•1) Outpatients or inpatients 18 years old <= age <= 65 years old, male or female;
•2) A psychiatric clinician performs DSM-IV fixed-form clinical examination (SCID) to screen patients with depression, and meets the ICD-10 depressive episode diagnostic criteria; diagnosis by Chinese medicine;
•3) Have sufficient audio-visual skills and comprehension skills, with an educational level above junior high school;
•4) Subjects signed a written informed consent form and volunteered to participate in this clinical study.

•1) Existing serious and active physical diseases that may interfere with the research treatment (abnormal indicators> 2 times the normal value), or the current physical disease medication and the study drug have a pharmacological conflict;
•2) Patients who meet the ICD-10 diagnostic criteria for other mental disorders (mental disorders such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, physical symptoms and related disorders);
•3) Pregnant or lactating women, or planning to become pregnant;
•4) Current serious suicide risk (eg HAMD-17 item 3 (suicide item) >= 3 points);
•5) Received electroconvulsive therapy (MECT) in the past month;
•6) According to the judgment of the investigator, there are other situations that are not suitable for participating in clinical trials.

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