Major depressive disorder
Conditions
Interventions
Individualized tACS intervention group:Individualized closed-loop tACS intervention for 4 weeks, with 5 sessions per week for a total of 20 treatment sessions, followed by follow-up through week 8.
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The cohort study intends to include three groups: patients with depression under high stress load (n=80), healthy individuals under high stress load (n=60), and healthy controls under low stress load (n=60). High stress load is defined as a score >=20 on the Perceived Stress Scale (PSS-10) and a total score >=300 on the Life Events Scale (LES), reflecting that individuals are in a state of high stress load in terms of both cognitive perception and actual stress exposure. (1) Inclusion criteria for patients with depression under high stress load: 1) Aged 18–65 years, regardless of gender; 2) Education duration >=6 years, right-handed; 3) Meet the diagnostic criteria for depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Mini International Neuropsychiatric Interview (MINI), without psychotic symptoms, and with a Hamilton Depression Rating Scale (HAMD-17) score >=14; 4) PSS-10 score >=20 and LES total score >=300; 5) No antidepressant medication received within 14 days prior to enrollment (patients who used fluoxetine prior to enrollment must discontinue use for at least 28 days); 6) Voluntary participation and signed written informed consent. (2) Inclusion criteria for healthy controls: 1) Aged 18–65 years, regardless of gender; 2) Education duration >=6 years, right-handed, and capable of undergoing EEG/MRI examinations; 3) No history of mental disorders or neurological diseases, confirmed by MINI structured clinical interview to have no current or past mental disorders; 4) High stress group: PSS-10 score >=20 and LES total score >=300; 5) Low stress healthy control group: PSS-10 score =20 and LES total score >=300; 4) HAMD-17 total score >=14 during the screening period and at baseline; 5) No antidepressant medication received within 14 days prior to enrollment (patients who used fluoxetine prior to enrollment must discontinue use for at least 28 days); 6) Able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Cohort Study (1) Previous or current severe neurological disorders, such as epilepsy, stroke, or traumatic brain injury; (2) Severe physical illnesses, such as malignant tumors, heart failure, or decompensated diabetes; (3) Comorbid severe psychiatric disorders, such as schizophrenia, bipolar disorder, substance dependence, or organic mental disorders; (4) History of alcohol or psychoactive substance abuse or dependence within the past year; (5) Pregnancy or lactation; (6) Contraindications to MRI examination, such as metal implants, cardiac pacemakers, or severe claustrophobia; (7) Inability to cooperate in completing questionnaires, neuropsychological assessments, or EEG/fMRI data acquisition. 2. Clinical Trial (1) History of epilepsy, hydrocephalus, central nervous system tumors, acute brain injury, or central nervous system infection; (2) A score of 3 or 4 on item 3 of the HAMD-17, indicating significant suicide risk, or a history of suicidal behavior; (3) Receipt of ECT, MECT, TMS, tDCS, tACS, or other neurostimulation treatment within 1 month before enrollment; (4) Pregnancy or lactation; (5) Severe organic disease or unstable medical condition caused by organic lesions; (6) Contraindications to MRI examination, such as metal implants, cardiac pacemakers, or severe claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAMD-17 score from baseline to the end of week 4.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HAMD-17 score from baseline to the end of week 2 and week 8.;Percentage reduction in HAMD-17 score from baseline to the end of week 2, week 4, and week 8.;Change in HAMA-14 score from baseline to the end of week 2, week 4, and week 8.;Percentage reduction in HAMA-14 score from baseline to the end of week 2, week 4, and week 8;Change and percentage reduction in MADRS score from baseline to the end of week 2, week 4, and week 8.;Change and percentage reduction in QIDS-SR16 and GAD-7 scores from baseline at each visit.;Change and percentage reduction in Perceived Stress Scale scores from baseline at different visit points.;Change and percentage reduction in resilience scale scores from baseline at different visit points.;Correlation between resilience scale scores and treatment efficacy.;Incidence of adverse events at each visit and overall.;Change in EEG indicators from baseline at each visit;Change in neuroimaging indicators from baseline at each visit;Change in functional near-infrared spectroscopy (fNIRS) measures from baseline at each visit.;Change in peripheral blood biomarkers from baseline at each visit;Response rate at each visit, defined as a >=50% reduction in HAMD-17 score from baseline.;Remission rate at each visit, defined as a HAMD-17 score <=7.;Change in patient compliance questionnaire scores from baseline at each visit.;Change in SHAPS scale scores from baseline at each visit.;Change in Chalder Fatigue Scale scores at each visit.;Change in Sheehan Disability Scale scores at each visit.;Change in Modified Apathy Evaluation Scale (MAES) scores at each visit.;Change in cognitive assessment scores from baseline at each visit.; | — |
Countries
China
Contacts
Public ContactLü Nan
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed