Not Yet RecruitingNot Applicable

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

China30 participantsStarted 2025-10-01

Plain-language 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 through standardized clinical assessments.To evaluate the safety of tACS treatment.To assess adverse events and side effects in both the intervention and control groups, ensuring the safety and tolerability of tACS in adolescent populations.

Who can participate

Age range12 Years – 18 Years

SexALL

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Inclusion criteria

✓.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 criteria

✕.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.

What they're measuring

Change in CDRS-R (Children's Depression Rating Scale) scores from baseline

Timeframe: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.

Trial details

NCT IDNCT07185464

SponsorFirst Affiliated Hospital of Chongqing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-30

Contact for this trial

Xinyu Zhou

15823996993 zhouxinyu@cqmu.edu.cn

View on ClinicalTrials.gov More Depression - Major Depressive Disorder trials