Major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Outpatients or inpatients aged between 18 and 65 years (inclusive), of any gender; 2.Diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), presenting with either a single or recurrent episode, without psychotic features; 3.A Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20 at both screening and baseline; 4.Patients must have been treated with at least one of the following antidepressants for >= 4 weeks prior to enrollment. Combination therapy is allowed with no more than two antidepressants, and the dosage must remain unchanged from enrollment to the end of study participation. Acceptable medications include: Selective serotonin reuptake inhibitors (SSRIs) Serotonin-norepinephrine reuptake inhibitors (SNRIs) Other commonly prescribed antidepressants. Additionally, the following medications are permitted for sleep support: Estazolam, Zolpidem Tartrate, Zopiclone, Eszopiclone, Dexzopiclone, and Zaleplon. 5.Able to understand and voluntarily agree to participate in the study, comply with the treatment protocol, and sign the written informed consent in person;
Exclusion criteria
Exclusion criteria: 1.Current or past diagnosis of other psychiatric disorders according to the DSM-; 2.Participation in other interventional neuromo; 3.Individuals deemed by the investigator to be at high risk for suicide at the time of screening; 4.Contraindications to MRI, including but not limited to intracranial metal implants, pacemakers, or cochlear implants; 5.Presence of skull defects (e.g., cranial cavities or fractures), inability to tolerate adverse effects, treatment-resistant epilepsy, or any other severe somatic illness that, in the investigator’s opinion, may interfere with the study intervention or outcomes; 6.Pregnant women; 7.Any other condition that, in the investigator’s judgment, makes the subject unsuitable for participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MADRS Score Reduction; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMA Score Reduction;Cognitive;VAS and IMS Score Reduction;QIDS-SR Score Reduction;YMSR Score Reduction;C-SSRS Score Reduction;SAS Score Reduction; | — |
Countries
China
Contacts
Beijing An Ding Hospital, Capital Medical University