Depressive disorder
Conditions
Interventions
10Hz Temporal Interference Stimulation group:10HZ TI stimulation:
10Hz TI stimulation (total 1200 sec):
ramp-up (30 sec) => stimulation (10Hz , 1.7mA channel 1’s electrode pair
2.3mA channel 2’s electrode pair, 4mA total, 1140 sec) => ramp-down (30 sec)
5Hz Temporal Interference Stimulation group:5HZ TI stimulation:
5Hz TI stimulation (total 1200 sec):
ramp-up (30 sec) => stimulation (5Hz , 1.7mA channel 1’s electrode pair
Sham stimulation group:Sham stimulation (total 1200 sec):
Electrodes will be placed on the head in the same locations as TI Intervention
Sponsors
Tianjin Anding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years (inclusive), regardless of gender; 2. Patients diagnosed with major depressive disorder (MDD) - current depressive episode by the study physician according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, including both first-episode and recurrent cases; 3. 17-item Hamilton Depression Rating Scale (HAMD-17) score of >=17; 4. Stable antidepressant treatment regimen maintained from 30 days prior to signing the informed consent form through the trial period. Patients using >2 antidepressant medications or combinations of antidepressants with augmentation agents must be adjusted to <=2 antidepressant combinations (Note: Antidepressant regimen refers to either monotherapy or combination therapy with one antidepressant plus another antidepressant/augmentation agent) at least 1 week prior to enrollment; 5. Demonstrated basic literacy and comprehension skills sufficient to complete study assessments; 6. Deemed by the study physician to comprehend the study objectives and procedures, capable of complying with the study protocol requirements, and willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. History of psychiatric disorders (other than MDD), neurological disorders, or substance use disorders that are ??deemed by the investigator to potentially interfere with outcome assessment??; 2. History of epilepsy or epileptiform convulsions; 3. Presence of ??intracranial metallic foreign bodies?? (e.g., shrapnel) or ??cardiac metallic implants?? (e.g., pacemakers, stents); 4. History of ??organic brain disorders??, significant head trauma, or neurosurgical procedures; 5. Received ??electroconvulsive therapy (ECT)?? or other neuromodulation treatments (e.g., repetitive transcranial magnetic stimulation [rTMS], transcranial direct/alternating current stimulation [tDCS/tACS]) ??within 30 days prior to enrollment??; ??6. Score >=3 on the suicide item?? (Item 3) of the 17-item Hamilton Depression Rating Scale (HAMD-17); ??7. Current pregnancy, lactation, or plans for conception during the trial period??; ??8. Concurrent participation in other interventional clinical trials??; ??9. Any other condition considered by the investigator to contraindicate study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale Scores change in depression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Scale Scores change in cognitive function;Scale Scores change in depression;Scale Scores change in depression;Scale Scores change in anhedonia;Scale Scores change in anxiety;Scale Scores change in sleep quality;Scale Scores change in quality of life;Scale Scores change in quality of life;Functional Magnetic Resonance Imaging;EEG signal; | — |
Countries
China
Contacts
Public ContactShen Li
Tianjin Anding Hospital
Outcome results
None listed