Status:
NOT_YET_RECRUITING
Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University
Conditions:
Depression - Major Depressive Disorder
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
To evaluate the efficacy of tACS treatment. To determine whether tACS can accelerate symptom remission, improve clinical response rates, and facilitate the recovery of emotional and cognitive function...
Detailed Description
This randomized, double-blind, sham-controlled pilot trial will evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) combined with stable pharmacotherapy in adolesce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07185451
Start Date
October 1 2025
End Date
October 1 2026
Last Update
September 22 2025
Active Locations (1)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 40000