Personalized brain stimulation treatment for adolescents with major depression
Neuroimaging Biomarker-guided Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Treatment for Major Depressive Episode in Adolescents With Mood Disorders: A Randomized Controlled Study
This study is testing a personalized brain stimulation treatment for teenagers with major depression to see if it works better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Jiangsu Province Nanjing Brain Hospital Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05498441 on ClinicalTrials.gov |
What this trial studies
This trial investigates the efficacy of a personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) treatment protocol for adolescents experiencing major depressive episodes. By utilizing neuroimaging biomarkers, the study aims to optimize stimulation parameters, including the selection of stimulation sites and electrode polarity, to enhance treatment outcomes. Participants will be adolescents aged 13 to 18 who meet the criteria for major depressive disorder or bipolar disorder and are currently on a stable medication regimen. The study will compare this personalized approach to standard HD-tDCS treatment to evaluate its safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13 to 18 diagnosed with major depressive disorder or bipolar disorder experiencing a moderate to severe depressive episode.
Not a fit: Patients who have undergone prior brain stimulation therapies or have comorbid psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for adolescents suffering from major depressive episodes who have not responded well to traditional medication.
How similar studies have performed: Previous studies have shown promising results for HD-tDCS in treating major depression, but this personalized approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 13 and 18 years of age; * Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for major depressive disorder (MDD) or bipolar disorder (BD); * Participants are assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL); * A current moderate or severe depressive episode defined by HAMD\>17; * Participants receive a stable psychotropic medication regimen prior to randomization to the trial and patient will be willing to remain on the stable regimen during the HD-tDCS treatment phase; * All participants provided written informed consent by themselves or their guardians after the detailed description of the study. Exclusion Criteria: * Prior rTMS, tDCS, electroconvulsive therapy (ECT) application or standard psychological therapy within 6 months prior to screening; * Comorbidity of other DSM-IV axis I disorders or personality disorders; * Judged clinically to be at serious suicidal risk; * Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities; * Unstable medical conditions, e.g., severe asthma; * Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases; * Mental retardation or autism spectrum disorder;Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metalimplants); * Contraindications to HD-tDCS (e.g., scalp rupture, cranial plates, history of seizure,electroencephalogram (EEG) test suggesting high risk of seizure, known brain lesion); * Current drug/alcohol abuse or dependence;Pregnant or lactating female.
Where this trial is running
Nanjing, Jiangsu
- Affiliated Nanjing Brain Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhongguo Zhang
- Email: zhangzhongguo1989@163.com
- Phone: +8615189204675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.