Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • tACS
  • tACS

Treatment groups

30 Participants
are divided into 2 treatment groups