Depression - Major Depressive DisorderNCT07185451
Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression
A study testing tACS in people with Depression - Major Depressive Disorder, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This randomized, double-blind, sham-controlled pilot study will evaluate the feasibility, acceptability, safety, and preliminary clinical effects of transcranial alternating current stimulation as an adjunctive treatment for adolescents with major depressive disorder. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- History of alcohol or substance abuse or dependence.
- Pregnant or breastfeeding females.
- Contraindications to MRI.
- Current high suicide risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 40000
Xinyu Zhou, 15823996993, zhouxinyu@cqmu.edu.cn
About this study
Official title: Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
This randomized, double-blind, sham-controlled pilot study will evaluate the feasibility, acceptability, safety, and preliminary clinical effects of transcranial alternating current stimulation as an adjunctive treatment for adolescents with major depressive disorder. The study will also explore changes in clinical symptoms, cognitive performance, and brain function following the intervention.
Read the detailed description
This randomized, double-blind, sham-controlled pilot trial will evaluate transcranial alternating current stimulation (tACS) as an adjunct to stable pharmacotherapy in adolescents with major depressive disorder (MDD). Eligible participants will be aged 12-18 years, meet DSM-5 criteria for a current depressive episode, have a Children's Depression Rating Scale-Revised (CDRS-R) score of at least 40, and have received stable antidepressant treatment for at least 4 weeks.
Thirty participants will be randomized 1:1 to active or sham stimulation while continuing their current medication. The active group will receive 20 sessions over 4 weeks using the NEXALIN ADI device (77.5 Hz, 15 mA, approximately 40 minutes per session). The sham device will be identical in appearance but will deliver no current. Participants and operators will remain blinded.
Primary outcomes will assess recruitment feasibility, intervention adherence, follow-up retention, and safety and tolerability. These will be evaluated through the number of participants enrolled over a recruitment period of up to 2 years, the number and proportion completing all 20 treatment sessions by Week 4, the number and proportion completing the Week 16 assessment, and the number and proportion experiencing adverse events or serious adverse events from the first stimulation session through Week 16. Pre-specified exploratory outcomes will assess changes in CDRS-R total scores and CDRS-R-defined response and remission rates, as well as changes in depressive and anxiety symptoms, suicidal ideation severity, overall illness severity, sleep quality, rumination, and pediatric health-related quality of life using the BDI-II, SCARED, HAMA, C-SSRS, CGI-S, PSQI, RRS, and PedsQL 4.0. Overall clinical improvement will be assessed using the CGI-I. Additional exploratory outcomes will include THINC-it cognitive performance, magnetic resonance imaging, electroencephalography, functional near-infrared spectroscopy, eye tracking, facial expression features, and acoustic features.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- tACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
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.
tACSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tACS | Experimental | Participants in this group will receive transcranial alternating current stimulation (tACS) in addition to their ongoing stable pharmacotherapy. tACS will be delivered using the NEXALIN ADI device (Beijing Neslin Technology Co., Ltd.) with a frequency of 77.5 Hz and current intensity of 15 mA. One electrode is placed on the forehead and two electrodes on the mastoid processes. Each session lasts approximately 40 minutes, with a total of 20 sessions administered over 4 weeks (5 sessions per week). The intervention aims to modulate cortical activity and improve depressive symptoms, cognitive function, and emotional regulation. Receives: Device: tACS |
| Sham | Sham comparator | Participants in this group will receive sham stimulation in addition to their ongoing stable pharmacotherapy. A sham device identical in appearance, sound, and operation to the active tACS device will be used but will not deliver any electrical current. Treatment is administered in the same schedule as the active group (20 sessions over 4 weeks, 5 sessions per week). Both participants and operators are blinded to the treatment assignment to ensure study integrity. Receives: Device: tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility (Number of Participants Enrolled)
The total number of participants successfully enrolled in this study will be recorded to assess recruitment feasibility. The goal is to recruit 30 participants (15 in each of the two groups) over a 2-year period.
Measured: From the start of recruitment to completion of enrollment, up to 2 years
Intervention adherence (number of participants who completed the full 20 treatment sessions)
This outcome measure will assess participants' adherence to the 20 sessions of transcranial alternating current stimulation. Adherence is defined as completing all 20 sessions. Adherence is calculated by dividing the number of participants who met this criterion by the total number of participants.
Measured: End of treatment at Week 4
Retention Rate (Number of Participants Remaining at 16-Week Follow-up)
This outcome measure will assess the proportion of participants still enrolled in the study at the 16-week follow-up assessment. Retention rate is calculated as the number of participants who completed the 16-Week assessment divided by the number of participants enrolled at baseline.
Measured: From randomization through the final follow-up assessment at Week 16
Incidence of Adverse Events and Serious Adverse Events
Adverse events, abbreviated as AEs, and serious adverse events, abbreviated as SAEs, will be assessed to evaluate the safety and tolerability of the intervention. An AE is defined as any unfavorable medical occurrence in a participant during the study period, regardless of whether it is considered related to the intervention. An SAE is defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is otherwise considered medically significant. The number and proportion of participants experiencing at least one AE or SAE will be recorded throughout the study period. The severity, outcome, and relationship to the intervention will also be documented.
Measured: From the first stimulation session through the final follow-up assessment at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Oct 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment design. Participants will be randomly allocated in a 1:1 ratio to either the active tACS group or the sham stimulation group. Both groups will continue stable pharmacotherapy throughout the study. The intervention group will receive 20 sessions of active tACS over 4 weeks, while the control group will receive sham stimulation with an identical device that delivers no current. Participants remain in their assigned group for the entire duration of the study without crossover.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185451
- Sponsor's protocol ID
- 1stChongqingMU__ZXY
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34969856Jones 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.
PubMed 35940423Yan 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 SQ, Yin YY, Yuan YG, Zhang AX, Zhang H, Zhang KR, Zhang L, Zhang ZJ, Zhou RB, Zhou YT, Zhu JJ, Zou CJ, Si TM, Zuo XN, Zhao JP, Zang YF. Reduced default mode network functional connectivity in patients with recurrent major depressive disorder. Proc Natl Acad Sci U S A. 2019 Apr 30;116(18):9078-9083. doi: 10.1073/pnas.1900390116. Epub 2019 Apr 12.
PubMed 30979801Chai 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):e2214505120. doi: 10.1073/pnas.2214505120. Epub 2023 Jun 20.
PubMed 37339227Wang 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.
PubMed 38476648Biackova 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.
PubMed 37682331Zhou 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.
PubMed 38880208Elyamany O, Leicht G, Herrmann CS, Mulert C. Transcranial alternating current stimulation (tACS): from basic mechanisms towards first applications in psychiatry. Eur Arch Psychiatry Clin Neurosci. 2021 Feb;271(1):135-156. doi: 10.1007/s00406-020-01209-9. Epub 2020 Nov 19.
PubMed 33211157Bowes L, Joinson C, Wolke D, Lewis G. Peer victimisation during adolescence and its impact on depression in early adulthood: prospective cohort study in the United Kingdom. Br J Sports Med. 2016 Feb;50(3):176-83. doi: 10.1136/bjsports-2015-h2469rep.
PubMed 26782765Consoli A, Peyre H, Speranza M, Hassler C, Falissard B, Touchette E, Cohen D, Moro MR, Revah-Levy A. Suicidal behaviors in depressed adolescents: role of perceived relationships in the family. Child Adolesc Psychiatry Ment Health. 2013 Mar 16;7(1):8. doi: 10.1186/1753-2000-7-8.
PubMed 23497551Hankin BL. Depression from childhood through adolescence: Risk mechanisms across multiple systems and levels of analysis. Curr Opin Psychol. 2015 Aug;4:13-20. doi: 10.1016/j.copsyc.2015.01.003.
PubMed 25692174Barker MM, Beresford B, Bland M, Fraser LK. Prevalence and Incidence of Anxiety and Depression Among Children, Adolescents, and Young Adults With Life-Limiting Conditions: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Sep 1;173(9):835-844. doi: 10.1001/jamapediatrics.2019.1712.
PubMed 31282938Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295.
PubMed 24005242