major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, male or female, outpatient or inpatient; 2. Suffering from major depressive disorder as diagnosed according to the DSM-5 criteria; 3. Currently experiencing a major depressive disorder episode lasting over 2 weeks but not exceeding 12 months; 4. Baseline Hamilton Depression Rating Scale (HAMD) total score >= 17 points; 5. Patients with the ability to sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Other current DSM-5 psychiatric disorders or Axis I disorders; 2. Treatment-resistant depression; 3. History of alcohol/substance use; 4. Individuals with serious suicide attempts or those with severe impulses; 5. Pregnant or lactating women who are unwilling to use contraception during the study period; 6. Patients with serious or unstable medical conditions deemed unsuitable by the researchers for participation in this study; 7. Patients with a history of neurological disorders (including seizures, brain injuries, multiple sclerosis, degenerative diseases such as amyotrophic lateral sclerosis, Parkinson's disease, and movement disorders); 8. Professional drivers or patients engaged in hazardous mechanical operations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events/adverse reactions;Changes in HAMD scores from baseline after 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective treatment rate;Clinical cure rate;Changes in HAMA scores from baseline after 8 weeks of treatment;Changes in PHQ-9 scores from baseline after 8 weeks of treatment;Changes in GAD-7 scores from baseline after 8 weeks of treatment;Withdrawal rate;Other laboratory indicators; | — |
Countries
China
Contacts
The Third Hospital of Mianyang