💬In plain words
What the trial is, and whether it could suit you
This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. Participants will be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care. Biological data, including neuroimaging, blood biomarkers, voice and facial features, Photoplethysmography (PPG), Electroencephalography (EEG), and behavioral data, will be collected to explore potential predictors of treatment response.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Between 12 and 18 years of age;
* Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K- SADS-PL, patients' age\< 18 years old);
* A current moderate or severe depressive episode defined by HAMD≥17 and Young Mania Rating Scale (YMRS) \<12;
* Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the HD-tDCS treatment phase;
* Participants and 1 or 2 parents (patients' age\< 18 years old) provide informed consent after the detailed description of the study.
Exclusion Criteria:
* Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment 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, metal implants);
* Contraindications to tDCS (e.g., metal in head, history of seizure, EEG test suggesting high risk of seizure, known brain lesion);
* Current drug/alcohol abuse or dependence;
* Pregnant or lactating female.
💊
What it tests
- Active HD-tDCS
- Antipsychotics, mood stabilizers, etc.
- Sham HD-tDCS
Affiliated Nanjing Brain Hospital, Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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