Depression
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Aged 18–70 years; (2) Meets the diagnostic criteria for a depressive episode as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) Vital signs are stable, the subject is alert, and able to cooperate with a physical examination and questionnaire; (4) Participants must be experiencing their first episode of the disorder, or must not have used antidepressants, mood stabilizers, or antipsychotic medications within 2 weeks prior to the start of treatment; (5) Mild to moderate depression with a baseline HAMD score > 8 and < 24; (6) Able to understand the study procedures and content, and willing to sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Diagnosed with a mental disorder other than depressive disorder (e.g., schizophrenia spectrum and related disorders, bipolar and related disorders, obsessive-compulsive and related disorders); (2) History of suicide attempts, currently at high risk of suicide, or a score of =3 on Item 3 (suicide score) of the HAMD Depression Scale; (3) Depressive episodes resulting from organic mental disorders caused by systemic or neurological diseases, such as depression caused by hypothyroidism; (4) Patients with severe or unstable systemic diseases affecting the cardiovascular, respiratory, hepatic, renal, endocrine, neoplastic, or hematological systems (including those with a tendency to bleed); (5) Patients with alcohol or drug dependence within the year prior to screening; (6) Inability to swallow oral medications, or a history of gastric or intestinal surgery, or other conditions that may affect drug absorption, distribution, metabolism, or excretion; (7) Pregnant or lactating women; (11) Head imaging revealing intracranial lesions such as leukoaraiosis, infarcts, tumors, or demyelination of the white matter; (12) Participants with metallic foreign bodies in the cranium, metal dentures in the mouth, cardiac pacemakers, cochlear implants, elevated intracranial pressure, or a history of epilepsy; (13) Participants with contraindications to MRI, such as claustrophobia or metallic implants; (14) Participants who, for other reasons, cannot undergo or complete the treatment as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMA ;SDS;SAS;PSQI;Traditional Chinese Medicine Syndrome Element Differentiation Scale for Depression;hs-CRP;NLR ;PLR ;MLR;IL-6;TNF-a;ALB ;CAR ;NPAR;fALFF;ReHo;FC; | — |
Countries
China
Contacts
Deyang People's Hospital