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

Обзор

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.

Подробное описание

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 first-episode, drug-naive major depressive disorder (MDD). Eligible participants are aged 12-18 years, meet DSM-5 criteria for a current depressive episode confirmed by K-SADS-PL, have a CDRS-R score ≥40, and have not received antidepressant treatment during the current episode.A total of 30 participants will be randomized 1:1 to receive either active tACS or sham stimulation, in addition to oral sertraline (25 mg/day in the first week, titrated to 50 mg/day thereafter). 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.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), mania symptoms (YMRS), suicide risk (C-SSRS), quality of life (PedsQL4.0), sleep (PSQI), rumination (RSS), 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.

Вмешательства

• Устройство tACS
  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 synchroniza
• Устройство tACS
  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.

Первичные конечные точки

• Change in CDRS-R (Children's Depression Rating Scale) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]

Вторичные конечные точки (8)

• Change in BDI-II (Baker Depression Scale) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale) [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]
• Change in RSS (Ruminative Responses Scale) [Срок оценки: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.]

Критерии участия

Критерии включения

1.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.

Критерии исключения

1.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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Публикации

• Hetrick SE, McKenzie JE, Bailey AP, Sharma V, Moller CI, Badcock PB, Cox GR, Merry SN, Meader N. New generation antidepressants for depression in children and adolescents: a network meta-analysis. Cochrane Database Syst Rev. 2021 May 24;5(5):CD013674. doi: 10.1002/14651858.CD013674.pub2. PMID 34029378
• Clancy KJ, Andrzejewski JA, You Y, Rosenberg JT, Ding M, Li W. Transcranial stimulation of alpha oscillations up-regulates the default mode network. Proc Natl Acad Sci U S A. 2022 Jan 4;119(1):e2110868119. doi: 10.1073/pnas.2110868119. PMID 34969856
• Jones KT, Johnson EL, Gazzaley A, Zanto TP. Structural and functional network mechanisms of rescuing cognitive control in aging. Neuroimage. 2022 Nov 15;262:119547. doi: 10.1016/j.neuroimage.2022.119547. Epub 2022 Aug 5. PMID 35940423
• Yan CG, Chen X, Li L, Castellanos FX, Bai TJ, Bo QJ, Cao J, Chen GM, Chen NX, Chen W, Cheng C, Cheng YQ, Cui XL, Duan J, Fang YR, Gong QY, Guo WB, Hou ZH, Hu L, Kuang L, Li F, Li KM, Li T, Liu YS, Liu ZN, Long YC, Luo QH, Meng HQ, Peng DH, Qiu HT, Qiu J, Shen YD, Shi YS, Wang CY, Wang F, Wang K, Wang L, Wang X, Wang Y, Wu XP, Wu XR, Xie CM, Xie GR, Xie HY, Xie P, Xu XF, Yang H, Yang J, Yao JS, Yao PMID 30979801
• Chai Y, Gehrman P, Yu M, Mao T, Deng Y, Rao J, Shi H, Quan P, Xu J, Zhang X, Lei H, Fang Z, Xu S, Boland E, Goldschmied JR, Barilla H, Goel N, Basner M, Thase ME, Sheline YI, Dinges DF, Detre JA, Zhang X, Rao H. Enhanced amygdala-cingulate connectivity associates with better mood in both healthy and depressive individuals after sleep deprivation. Proc Natl Acad Sci U S A. 2023 Jun 27;120(26):e2214 PMID 37339227
• Wang J, Zhao W, Wang H, Leng H, Xue Q, Peng M, Min B, Jin X, Tan L, Gao K, Wang H. Brain-wide activation involved in 15 mA transcranial alternating current stimulation in patients with first-episode major depressive disorder. Gen Psychiatr. 2024 Mar 8;37(2):e101338. doi: 10.1136/gpsych-2023-101338. eCollection 2024. PMID 38476648
• Biackova N, Adamova A, Klirova M. Transcranial alternating current stimulation in affecting cognitive impairment in psychiatric disorders: a review. Eur Arch Psychiatry Clin Neurosci. 2024 Jun;274(4):803-826. doi: 10.1007/s00406-023-01687-7. Epub 2023 Sep 8. PMID 37682331
• Zhou J, Li D, Ye F, Liu R, Feng Y, Feng Z, Li R, Li X, Liu J, Zhang X, Zhou J, Wang G. Effect of add-on transcranial alternating current stimulation (tACS) in major depressive disorder: A randomized controlled trial. Brain Stimul. 2024 Jul-Aug;17(4):760-768. doi: 10.1016/j.brs.2024.06.004. Epub 2024 Jun 14. PMID 38880208

Идентификаторы

NCT: NCT07185464 · 1stChongqingMU___ZXY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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