Major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the DSM-5 diagnostic criteria for anxiety depression; 2. Never take antidepressants before enrollment, terminate the medication for more than 14 days (patients taking fluoxetine treatment should stop taking the medication for at least 28 days); 3. HAMD-17 level >= 18 points and meet the total HAMD anxiety/somatic factor score >= 7 points (including entry 10-mental anxiety, entry 11-somatic anxiety, entry 12-gastrointestinal symptoms, entry 13-general symptoms, entry 15-suspicion, entry 17-self-awareness, a total of 6 items), and the anxiety level of the current episode HAMA >= 14 points; 4. Age 18-45 years old, right-handed, and with an education level of junior high school or above; 5. Gender is not limited; 6. Patients voluntarily participated and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Current or prior diagnosis of a major psychiatric disorder other than a depressive disorder consistent with the DSM-5, such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, obsessive-compulsive disorders, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse, personality disorders, or history of depressive disorders secondary to other psychiatric disorders; 2. Neurologic disorders, such as brain tumors, cerebrovascular events, epilepsy, neurodegenerative diseases, or previous brain surgery; 3. standard contraindications to MRI (e.g., immovable metal objects in and around the body, claustrophobia) or pregnant or lactating women; 4. Electroconvulsive therapy in the 3 months prior to enrollment; 5. any other circumstance that, in the opinion of the investigator, makes participation in the study unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17 subtraction before and after treatment (baseline vs 1 week); | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMD-17 effective rate at week 1 (effective: >=50% reduction in HAMD-17 score from baseline) ;Trend in HAMD score reduction from baseline for each day of treatment ((HAMD-17pre-HAMD-17post)/ HAMD-17pre*100%);HAMD-17 remission rate by time point (remission HAMD-17 score <= 7); | — |
Countries
China
Contacts
Beijing Anding Hospital, Capital Medical University