Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Treatment for Major Depressive Episode

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Adolescents with mood disorders experiencing major depressive episode have poor efficacy of medication treatment. High-Definition Transcranial Direct Current Stimulation (HD-tDCS) has been proven adjuvant efficacy in patients with major depressive episode. However, the optimal evidence-based stimulation parameters have not been clearly defined, which greatly limits the efficacy of HD-tDCS in the treatment of major depressive episode.This trial will compare a novel form of accurate and personalized HD-tDCS treatment protocol guided by neuroimaging biomarkers to the routine stimulation(stimulation target is L-DLPFC, central electrode is anode).The personalized selection of stimulation site, central electrode polarity will be determined by neuroimaging biomarkers. The study aims to propose a novel personalized neuroimaging-guided HD-tDCS strategy, to evaluate the efficacy and safety of the treatment, further to understand the biological mechanism of the personalized HD-tDCS treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Province Nanjing Brain Hospital
• Treatments: Quetiapine Fumarate

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,MADRS≥30 and YMRS<12;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;Participants and 1 or 2 parents provide informed consent 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.