tACS plus stable medication for teens with major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, sham-controlled pilot evaluates transcranial alternating current stimulation (tACS) as an adjunct to stable pharmacotherapy in adolescents with major depressive disorder. Thirty participants aged 12-18 will be assigned to active or sham tACS for 20 sessions over four weeks, using the NEXALIN ADI device. Primary goals focus on feasibility, adherence, retention, and safety, with exploratory outcomes including changes in CDRS-R scores and response/remission rates. Assessments include clinical, cognitive, and brain-function measures, with follow-up through Week 16.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 12-18 years.
2. Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL.
3. Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline.
4. Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.

Exclusion Criteria:

1. Psychiatric comorbidities other than anxiety disorders.
2. Depression with psychotic features.
3. Young Mania Rating Scale (YMRS) score \>13.
4. History of neurological disorders (e.g., epilepsy, traumatic brain injury) or severe physical illnesses (e.g., thyroid disease, lupus, diabetes, significant liver, kidney, or lung impairment, major trauma).
5. Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies.
6. Current use of antiepileptic drugs or high-dose benzodiazepines.
7. History of alcohol or substance abuse or dependence.
8. Pregnant or breastfeeding females.
9. Contraindications to MRI.
10. Current high suicide risk.

Where it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Xinyu Zhou
• Email: zhouxinyu@cqmu.edu.cn
• Phone: 15823996993

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.