Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression
Recruiting · NCT07185451 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
tACS
What this trial is about
This randomized, double-blind, sham-controlled pilot study will evaluate the feasibility, acceptability, safety, and preliminary clinical effects of transcranial alternating current stimulation as an adjunctive treatment for adolescents with major depressive disorder. It will also examine changes in depressive symptoms and related clinical outcomes, while exploring potential effects on emotional regulation, cognitive function, and brain function following the intervention.
Who can take part
Age range
12 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 12-18 years.
- Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL.
- Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline.
- Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.
Exclusion criteria
- Psychiatric comorbidities other than anxiety disorders.
- Depression with psychotic features.
- Young Mania Rating Scale (YMRS) score \>13.
- 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).
- Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies.
- Current use of antiepileptic drugs or high-dose benzodiazepines.
- History of alcohol or substance abuse or dependence.
- Pregnant or breastfeeding females.
- Contraindications to MRI.
- Current high suicide risk.
Where it is running
1 location listed.
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, Chongqing Municipality, China