Depression disorder
Conditions
Interventions
Experimental Group 1(Single-target stimulation of the right amygdala):Participants will receive temporal interference electrical stimulation (TIS) targeting the right amygdala.
Experimental Group 2(Single-target stimulation of the right nucleus accumbens):Participants will receive temporal interference electrical stimulation (TIS) targeting the right nucleus accumbens.
Experimental Group 3(Dual-target stimulation of the right amygdala and right nucleus accumbens):Participants will receive dual-target temporal interference electrical stimulation (TIS) simultaneously
Sham stimulation group:Participants will receive sham temporal interference electrical stimulation using the TIS device.
Sponsors
Beijing Huilongguan Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Fulfillment of the diagnostic criteria for Major Depressive Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2.Age >= 18 years; Han Chinese ethnicity; no restriction on sex; 3.Hamilton Depression Rating Scale, 17-item version (HAMD-17) score >=17 at screening; 4.Right-handed; normal or corrected-to-normal visual acuity; 5.Receiving a stable pharmacological treatment regimen, which will be maintained unchanged throughout the intervention period (either no medication or stable antidepressant type and dosage). 6.Willingness to participate in the study and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Current or past diagnosis of any major psychiatric disorder other than Major Depressive Disorder according to DSM-5, including but not limited to other psychotic disorders, substance-related and addictive disorders, substance/medication-induced psychotic disorders, neurodevelopmental disorders, and neurocognitive disorders; 2.Presence of severe medical conditions that, in the investigator’s judgment, render the individual unsuitable for participation in the study; 3.Pregnant women, women within 6 months postpartum, or women who are currently breastfeeding; 4.Presence of major neurological disorders or implanted electronic medical devices (e.g., cardiac pacemakers, deep brain stimulation electrodes), or any condition rendering the participant unsuitable for receiving physical/electrical stimulation; 5.Individuals with a high current risk of suicide or those unable to adequately comply with treatment procedures and data collection; 6.Receipt of electroconvulsive therapy (ECT or MECT), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) within the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD);Hamilton Anxiety Rating Scale (HAMA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory (BDI);Self-Rating Anxiety Scale (SAS); | — |
Countries
China
Contacts
Public ContactZhiren Wang/Xuteng Wang
Beijing Huilongguan Hospital affiliated to Capital Medical University
Outcome results
None listed