Depressive Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All subjects must meet the following inclusion criteria: 1. According to screening SCID-5, meet the diagnostic criteria for major depressive disorder in the fifth edition of the American 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5); 2. Total score >=17 on the Hamilton Depression Rating Scale (HAMD-17); 3. First episode, duration <=1 year; 4. Age between 18 and 60 years old; 5. Right-handed, Han Chinese; 6. No diarrhea within the past 3 months, no use of antibiotics; 7. Subjects are informed and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Patients meeting other DSM-5 Axis I diagnoses, such as but not limited to schizophrenia, bipolar disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder, delirium, dementia, and memory impairment; 2) According to DSM-5, patients with dementia, delirium, or other amnesic disorders; diagnosed with a severe organic brain syndrome; or previous or current systemic illness that may impair cognitive ability or other neuropsychiatric functions (documented head trauma with loss of consciousness or significant cognitive or behavioral sequelae, epileptic seizures, stroke, neurodegenerative disease, etc.); 3) Patients with a history of epilepsy, febrile seizures, or coma; 4) Patients meeting DSM-5 criteria for alcohol or drug dependence (excluding nicotine dependence); alcohol or drug dependence within the past 12 months, or substance abuse within the past three months, excluding nicotine; 5) High suicide risk: Patients with serious suicidal behavior (defined as self-harm with the intent to die) in the past six months prior to screening, or those judged by the investigator to be at high suicide risk are not suitable for inclusion in this study; 6) Patients cannot be treated with the "Shengyang Xingshen" acupuncture method; 7) In the opinion of the investigator, any clinically significant abnormal laboratory data, vital signs, or physical examination results at screening or baseline that may interfere with safety evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage reduction in Hamilton scale total score; | — |
Secondary
| Measure | Time frame |
|---|---|
| General Clinical Information;Hamilton Anxiety Rating Scale;Beck Scale for Suicide Ideation;Young Mania Rating Scale;Medication Side Effect Rating Scale;Quantitative Scale for Traditional Chinese Medicine Syndromes;MATRICS consensus cognitive battery;Numeric Rating Scale for Pain (NRS);Clinical Global Impression - Global Improvement Scale (CGI-GI); | — |
Countries
China
Contacts
The Affiliated Brain Hospital of Guangzhou Medical University