Depressive Disorder
Conditions
Interventions
Gold Standard:The gold standard for diagnosing depression is the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and the International Classification of Diseases, Tenth R
Index test:The Hamilton Depression Rating Scale (HAMD), EEG microstates , heart rate acquisition, selective serotonin reuptake inhibitors (SSRIs) as antidepressants, and the establishment of a brain-c
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: depression group 1. Age is between 18 and 65 years old (inclusive of the boundary values); 2. Subjects must have a full understanding of the trial content, process, and potential adverse reactions, and voluntarily sign the Informed Consent Form (ICF); 3. Subjects must meet the diagnostic criteria for major depressive disorder (MDD) without psychotic features as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), for either recurrent episodes or a single episode of MDD, and have a total score of 22 or higher on the Hamilton Depression Rating Scale-17 (HAMD-17); 4. As judged by the investigator, the subject is in generally good physical condition, with no clinically significant abnormalities observed during screening in physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (complete blood count, blood biochemistry, thyroid function, coagulation function, urinalysis, etc.), and chest X-ray (anteroposterior and lateral) or chest CT; 5. Female subjects of childbearing age with a negative blood ß-human chorionic gonadotropin (ß-hCG) test at screening/baseline; control group 1. There were no reports of depressive symptoms within the matched age range; 2.The total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) was less than 22 points; 3. There were no past or current psychiatric diagnoses; 4. There was no history of cognitive impairment or neurological diseases; 5. And there was no history of drug abuse or alcoholism;
Exclusion criteria
Exclusion criteria: depression group 1. According to DSM-5 diagnostic criteria, subjects currently or previously have schizophrenia spectrum or other psychotic disorders, bipolar or related disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, dissociative disorders, anorexia nervosa or bulimia nervosa, personality disorders, etc; 2. A history of epileptic seizures (excluding convulsions caused by febrile seizures in childhood); 3. A history of other somatic diseases, particularly neurological disorders and history of traumatic brain injury; 4. A history of severe allergies; 5. A history of alcohol or drug dependence/abuse within the past year (including benzodiazepines, excluding nicotine or caffeine), or a positive urine drug test at screening; 6. Any other condition, as assessed by the investigator, that may interfere with compliance, compromise the subject's health, or interfere with the study outcomes. control group 1. The following criteria were met within the matched age range: Reports of depressive symptoms; 2. A total score of >=22 on the 17-item Hamilton Depression Rating Scale (HAMD-17); 3. Past diagnosis of other severe psychiatric disorders; 4. History of other somatic diseases, especially neurological diseases or history of traumatic brain injury; 5. History of severe cognitive impairment or neurological diseases; 6. History of drug abuse or alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (HAMD);Microstate;Heart Rate Variability (HRV) Data;Diagnostic accuracy of MLP model; | — |
Secondary
| Measure | Time frame |
|---|---|
| EEG microstate features; | — |
Countries
China
Contacts
Public ContactMengqian Li
The First Affiliated Hospital of Nanchang University
Outcome results
None listed