Major Depressive Disorder
Conditions
Interventions
Accelerated tACS stimulation treatment group:Apply 77.5Hz, 15 mA high-current tACS for a single session lasting 40 minutes, with treatment administered twice daily for 10 consecutive days, totaling 20
Conventional tACS stimulation treatment group:Apply 77.5Hz, 15 mA high-current tACS for a single session lasting 40 minutes, with treatment administered twice daily. The two sessions are one real and
Control Group (Waitlist Group):The electrode placement is the same as in the previous two groups, with current only generated before and after the treatment, and no current during the treatment. The p
Sponsors
Hangzhou Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Outpatient or inpatient patients aged 18 to 55 years (inclusive), male or female; 2) Right-handed; 3) Han Chinese ethnicity; 4) Middle school education or higher; 5) Diagnosed with major depressive disorder (MDD) according to DSM-5 criteria, either a single episode (F32.1, F32.2) or recurrent episodes (F33.1, F33.2); 6) HAMD17 total score > 17 during both the screening and baseline phases; 7) This study involves combined medication therapy, and at the time of enrollment, participants may only be taking one SSRI, SNRI, or NaSSA-class antidepressant. If participants are using other antidepressant medications, they must discontinue the use of such medications for at least 5 half-lives before randomization.
Exclusion criteria
Exclusion criteria: 1.Patients who meet the diagnostic criteria for other mental disorders according to DSM-5 (e.g., schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc.); 2.Patients who answer "Yes" to item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) during the screening phase, or those with a history of significant suicidal tendencies within the past 12 months, and/or those who, based on the clinician's assessment, are deemed to be at risk for suicidal or violent behavior; 3.Patients with depressive episodes secondary to a systemic disease or a neurological disorder, such as depression caused by hypothyroidism; 4.Patients with a =25% reduction in the total score on the HAMD17 compared to baseline; 5.Patients with severe or unstable cardiovascular conditions (e.g., hypertension, heart disease), respiratory, liver, kidney, blood, endocrine, neurological, or other systemic diseases; 6.Patients with any severe neurological disease or impairment, including but not limited to: any condition that may be associated with increased intracranial pressure, space-occupying brain injuries, a history of seizures, brain aneurysms, Parkinson's disease, Huntington's chorea, multiple sclerosis, or severe head trauma with loss of consciousness; 7.Patients with intracranial metal implants or electronic components (e.g., aneurysm clips, shunts, stimulators, arterial stents, cochlear implants, or electrodes) or other metal implants near the cranium (excluding oral implants) that cannot be safely removed; 8.Patients with alcohol or substance dependence within the past 6 months prior to screening; 9.Pregnant women; 10.Patients who have participated in any other clinical trial within 1 month prior to baseline; 11.Patients whom the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroencephalogram (EEG); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale (HAMA);Hamilton Depression Rating Scale (HAMD);C-SSRS;Any adverse events; | — |
Countries
China
Contacts
Public ContactDeng Wei
Hangzhou Seventh People's Hospital
Outcome results
None listed