Major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for depression as outlined in the American Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 2.First episode, with a disease duration of less than three years; 3.Informed consent obtained from the patient and/or legal guardian or immediate family member, with a signed informed consent form;
Exclusion criteria
Exclusion criteria: 1.History of organic brain disease or head trauma with loss of consciousness exceeding one hour; marked intellectual disability; history of epileptic seizures; 2.Presence of other severe or uncontrolled systemic diseases, such as hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or haematological disorders; 3.Current (within 3 months) alcohol or substance abuse, or prior history of dependence; 4.Presence of negative risks such as self-harm or suicide; 5.Participation in other drug clinical trials within 1 month prior to screening; 6.Abnormal screening/baseline laboratory results (excluding liver and kidney function, where laboratory values exceed normal range 1.5 times the upper limit of normal, unless deemed clinically insignificant by the investigator; no significant abnormalities in other ancillary tests); 7.Pregnant or lactating women; women of childbearing potential with positive urine pregnancy test; 8.Hearing impairment (inability to hear or understand the investigator's speech during normal conversation); 9.Visual impairment (red, green, blue or yellow blindness or colour deficiency); 10.Inability to walk independently (requiring crutches, wheelchair or similar aids); 11.Peripheral nerve damage affecting test operation; 12.Contraindications for magnetic resonance imaging (MRI) scans, such as the presence of metallic or electronic devices within the body (e.g., intracranial metallic foreign bodies, cochlear implants, cardiac pacemakers, stents, or other metallic implants); 13.High suicide risk, with HAMD-17 item 3 score =2 or MARDS item 10 score =3; 14.Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for post-traumatic stress disorder, panic disorder, or schizophrenia; 15.History of severe physical illness or conditions potentially affecting the central nervous system; 16.Risk of neurological disorders or seizures, such as prior history of intracranial disease, head trauma, abnormal electroencephalogram findings, MRI evidence of brain structural abnormalities, or family history of epilepsy; 17. Long-term use of anticholinergic drugs; 18. Abuse (dependence) on psychoactive substances;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD-17) and Hamilton Anxiety Rating Scale (HAMA-17) score reduction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Five Facet Mindfulness Questionaire; | — |
Countries
China
Contacts
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University