Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07185451

Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Depression - Major Depressive Disorder

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 40000, China

Location contact

Xinyu Zhou

CONTACT

[email protected]

15823996993

About this study

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 adolescents with major depressive disorder (MDD). Eligible participants are aged ≥8 years, meet DSM-5 criteria for a current depressive episode, have a CDRS-R score ≥40, and have been on stable antidepressant treatment for at least 4 weeks.

A total of 30 participants will be randomized 1:1 to receive either active tACS or sham stimulation, in addition to their ongoing medication. The active group will undergo 20 sessions over 4 weeks (5 sessions per week) using the NEXALIN ADI device (77.5 Hz, 15 mA, ~40 minutes per session). The sham device is identical in appearance but delivers no current. Both participants and operators will remain blinded.

The primary outcomes are changes in depressive symptoms measured by the CDRS-R and BDI. Secondary outcomes include anxiety (SCARED, HAMA), global improvement (CGI-S, CGI-I), suicide risk (C-SSRS), quality of life (PedsQL), sleep (PSQI), rumination (RRS), and cognition (THINC-it). Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments.

This pilot study will provide preliminary evidence on the potential of tACS as an adjunctive treatment for adolescent depression and inform future large-scale trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tACS

Device

This intervention uses the NEXALIN ADI alternating current stimulation device from Beijing Naisilin Technology Co., Ltd., to deliver targeted stimulation to the prefrontal cortex and bilateral mastoid regions. The prefrontal cortex electrode directly stimulates the cerebral cortex, while the mastoid electrodes ensure the synchronized activation of bilateral neural pathways. Stimulation is applied at a frequency of 77.5 Hz and a current intensity of 15 mA, aiming to optimize brainwave synchronization and modulate brain activity.

Participants will undergo daily sessions lasting approximately 40 minutes each, for a total of 20 sessions over 4 weeks. The non-invasive nature of the intervention, combined with its precise targeting of specific brain regions, distinguishes it from other neuromodulation therapies. The treatment aims to enhance neural synchronization, promote neuroplasticity, and provide a non-pharmacological therapeutic alternative for patients.

Primary outcomes

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

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

    Clinical response (≥ 50% reduction in CDRS-R scores from baseline)

Secondary outcomes

  1. Change in BDI-II (Baker Depression Scale) scores from baseline

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

    Change in BDI-II (Baker Depression Scale) scores from baseline

  2. Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline

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

    Improvement in anxiety (SCARED minus the scores）

  3. Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)

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

    The severity of the suicide risk

  4. Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline

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

    Improvement in sleep status (PSQI minus the scores）

  5. Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline

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

    Improvement of children's quality of life（PedsQL4.0 minus the scores)

  6. Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline

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

    Improvement in overall clinical impression severity（ 7-point scale, with 1 being normal and 7 being among the most severely damaged）

  7. Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline

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

    Improvement of clinical general Impression scale（ 7-point scale,7 denoting a very significant deterioration）

  8. Change in RSS (Ruminative Responses Scale)

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

    The level of improvement in negative thinking（he higher the total score, the more reflective thinking The more severe it is）

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyu Zhou

CONTACT

[email protected]

15823996993

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.