Major depression disorder
Conditions
Interventions
Low-frequency deviation groups A and B:Transcranial alternating current stimulation (tACS) treatment.
High-frequency deviation groups A and B:Transcranial alternating current stimulation (tACS) treatment.
Precision-matched group:Transcranial alternating current stimulation (tACS) treatment.
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Participants aged 18 to 65 years; 2.Participants diagnosed with major depressive disorder (MDD) by a psychiatrist using the Structured Clinical Interview based on DSM-5; 3.A HAMD-17 total score of >=17 and a score of >=2 on item 1 (depressed mood); 4.Participants on a stable antidepressant regimen, limited to SSRIs (e.g., fluoxetine, paroxetine, citalopram), with a stable dosage for >=4 weeks before enrollment; 5.Participants who have provided written informed consent and agreed to receive tACS intervention and multimodal monitoring.
Exclusion criteria
Exclusion criteria: 1.Current or past comorbid Axis I psychiatric disorders (including hypomanic or manic episodes, panic disorder, agoraphobia, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, psychotic disorders, anorexia nervosa, bulimia nervosa, and generalized anxiety disorder), and Axis II antisocial personality disorder assessed by the Chinese version of MINI 5.0.3; 2.Current or past history of organic brain disease or neurological disorders; 3.Participants with a score of =3 on the suicide item of the HDRS-17, indicating acute suicide risk; 4.Participants currently receiving ECT, MECT, TMS, tDCS, tACS, or other neuromodulation interventions; 5.Presence of cochlear implants, cardiac pacemakers, or intracranial implants/metallic devices; 6.Participants currently taking non-SSRI antidepressants (including SNRIs, NaSSA, tricyclics, MAOIs), concomitant use of any medication known to significantly affect REM sleep (e.g., benzodiazepines, antipsychotics, sedative-hypnotics, antiepileptics), unstable antidepressant treatment (e.g., dose adjusted within the past 4 weeks), a history of substance abuse, or use of drugs influencing neurophysiological function (e.g., phenobarbital, valproate); 7.Participants who are pregnant or breastfeeding; 8.Participants who are currently enrolled in other clinical trials; 9.Participants with contraindications to electric field stimulation, such as epilepsy, uncontrolled severe cardiovascular disease, implanted electronic devices, or metallic implants in the head; 10.Participants who refuse to provide written informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale 17-item;Polysomnography (PSG); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale (HAMA);Pittsburgh Sleep Quality Index (PSQI);Epworth Sleepiness Scale (ESS);Clinical Global Impression Scale;Neurophysiological indicators; | — |
Countries
China
Contacts
Public ContactDanjuan Wu
The First Affiliated Hospital of Ningbo University
Outcome results
None listed