Major Depressive Disorder
Conditions
Keywords
Adolescents, Deep Brain Stimulation, Major Depressive Disorder, Temporal Interference, Amygdala
Brief summary
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in adolescent depressive disorders.
Interventions
DEVICENervio-X
An 8-channel TIS device developed by NEURODOME Corporation.
Sponsors
Ruijin Hospital
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Participants must be aged between 14 and 18, with no gender restrictions; * A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); * HAMD-17 score of 17 or higher; * Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment; * Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form.
Exclusion criteria
* Eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy; * Participants must not have a history of seizures or prior episodes of epilepsy; * The presence of metallic foreign objects within the cranial structure or metallic cardiac implants; * Participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention; * Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy); The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior; * Pregnant or breastfeeding; * Participants who are concurrently engaged in other clinical interventional trials; * Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAMD-17 | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | — |
| HAMA | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | — |
| MADRS | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | — |
| PHQ-A | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | — |
| GAD-7 | Baseline, after treatment, 1 week, 4 weeks and 8 weeks | — |
| SHAPS | Baseline, 4 weeks and 8 weeks | — |
| PSQI | Baseline, 4 weeks and 8 weeks | — |
| SF-36 | Baseline and 8 weeks | — |
| WHOQOL-BREF | Baseline and 8 weeks | — |
| ARI | Baseline and 8 weeks | — |
| OSI | Baseline, 4 weeks and 8 weeks | For use when the patient exhibits self-harming behavior |
Countries
China
Contacts
Primary ContactJINGJING HUANG, MD PhD
Backup ContactChencheng Zhang, MD PhD
Outcome results
None listed