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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

ConditionDepression - Major Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • tACS

    Device

    In the sham stimulation group, participants will receive intervention using a sham device that is identical in appearance, operation, and stimulation protocol to the real tACS device, but does not deliver any current. Both participants and operators will be unable to distinguish between real and sham stimulation based on the device's appearance, sound, or tactile feedback. Device allocation will follow a randomized code generated in advance to ensure blinding and proper group assignment.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: tACSExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

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

Secondary outcomes

1

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

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.
2

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

Improvement in anxiety (SCARED minus the scores）

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

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

The severity of the suicide risk

Time frame
Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.
4

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

Improvement in sleep status (PSQI minus the scores）

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Chongqing Medical University

Lead sponsor

Source ClinicalTrials.gov

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