Status:
NOT_YET_RECRUITING
Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) in Adolescents With First-episode Depression Who Are Drug-naive: 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 functions...
Detailed Description
This randomized, double-blind, sham-controlled pilot trial will evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) combined with sertraline in adolescents with fir...
Eligibility Criteria
Inclusion
- Age 12-18 years; 2.Subjects met the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as determined by the Childhood Affective Disorders and Schizophrenia Questionnaire (K-SADS-PL) and were currently in a depressive episode; 3.Children's Depression Rating Scale-Revised (CDRS-R) score ≥ 40 points; 4.Not receiving any antidepressant medication during the current depressive episode.
Exclusion
- Other comorbid mental disorders in accordance with DSM-5 except anxiety disorders; 2.Depression with psychotic symptoms; 3.Young Mania Rating Scale (YMRS) \> 13; 4.History of neurological disease (such as epilepsy, brain trauma, etc.) or serious physical disease (such as thyroid disease, lupus erythematosus, diabetes, lung, liver and kidney damage, major trauma, etc.); 5.Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS or other neurostimulation treatments; 6.Patients currently receiving anti-epileptic drugs or high-dose benzodiazepines; 7.History of alcohol or drug abuse or dependence; 8.Breastfeeding women or pregnant women; 9.Contraindications to MRI; 10.Currently at high risk of suicide.
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
NCT07185464
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