Depression - Major Depressive DisorderNCT07185464

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

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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… 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: Pill or oral medicine, 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 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xinyu Zhou contact

15823996993

zhouxinyu@cqmu.edu.cn

China1 site

The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 40000
Xinyu Zhou, 15823996993, zhouxinyu@cqmu.edu.cn

Other trials in China

About this study

Read the detailed description

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.

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 groups in NCT07185464
Study group	Role	What they receive
tACS	Experimental	Participants in this group will receive transcranial alternating current stimulation (tACS) in addition to daily oral sertraline. tACS will be administered using the NEXALIN ADI device (Beijing Neslin Technology Co., Ltd.) with stimulation parameters set at a frequency of 77.5 Hz and a current intensity of 15 mA. One electrode will be placed on the forehead and two electrodes on the mastoid processes. Each session will last approximately 40 minutes, with a total of 20 sessions delivered across 4 consecutive weeks (5 sessions per week). The intervention is designed to modulate abnormal cortical oscillations, thereby alleviating depressive symptoms, enhancing cognitive performance, and supporting emotional regulation. Receives: Device: tACS
Sham	Sham comparator	Arm Description: Participants in this group will receive sham stimulation in addition to daily oral sertraline. A sham device, identical in appearance, sound, and operation to the active tACS device, will be used but will not deliver any electrical current. Sessions will follow the same schedule as the active group (20 sessions over 4 weeks, 5 sessions per week). Both participants and operators will remain blinded to treatment allocation to maintain trial integrity. Receives: Device: tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
Clinical response (≥ 50% reduction in CDRS-R scores from baseline)
Measured: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.

Secondary outcomes (8)

Change in BDI-II (Baker Depression Scale) scores from baseline
Change in BDI-II (Baker Depression Scale) scores from baseline
Measured: 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
Improvement in anxiety (SCARED minus the scores）
Measured: 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)
The severity of the suicide risk
Measured: 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
Improvement in sleep status (PSQI minus the scores）
Measured: 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
Improvement of children's quality of life（PedsQL4.0 minus the scores)
Measured: 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
Improvement in overall clinical impression severity ( 7-point scale, with 1 being normal and 7 being among the most severely damaged )
Measured: 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
Improvement of clinical general Impression scale (7-point scale,7 denoting a very significant deterioration)
Measured: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.
Change in RSS (Ruminative Responses Scale)
The level of improvement in negative thinking(the higher the total score, the more reflective thinking the more severe it is).
Measured: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20251 Oct 2026

First posted22 Sep 2025
Study start1 Oct 2025 (estimated)
Primary completion30 Mar 2026 (estimated)
Study completion1 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
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 adopts a parallel assignment design. Participants will be randomized in a 1:1 ratio to either the active tACS group or the sham stimulation group, with all participants receiving oral sertraline throughout the trial. The intervention group will undergo 20 sessions of active tACS over 4 weeks, while the control group will receive sham stimulation using an identical device that delivers no current. Participants will 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07185464
Sponsor's protocol ID: 1stChongqingMU___ZXY
Status last verified: Sep 2025
First submitted: 15 Sep 2025
Last updated: 22 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 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.
PubMed 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.
PubMed 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 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 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):e2214505120. doi: 10.1073/pnas.2214505120. Epub 2023 Jun 20.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 38880208
Elyamany 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 33211157
Bowes 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 26782765
Consoli 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 23497551
Hankin 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 25692174
Barker 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 31282938
Beardslee 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

Interested in taking part?

Xinyu Zhou

15823996993

zhouxinyu@cqmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07185464
Acronym / sponsor ID: 1stChongqingMU___ZXY
Conditions: Depression - Major Depressive Disorder
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
Study start: 1 Oct 2025 (estimated)
Primary completion: 30 Mar 2026 (estimated)
Study completion: 1 Oct 2026 (estimated)
First posted: 22 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This study adopts a parallel assignment design. Participants will be randomized in a 1:1 ratio to either the active tACS group or the sham stimulation group, with all participants receiving oral sertraline throughout the trial. The intervention group will undergo 20 sessions of active tACS over 4 weeks, while the control group will receive sham stimulation using an identical device that delivers no current. Participants will remain in their assigned group for the entire duration of the study without crossover.

Arm	Type	Receives
tACS	Experimental	Device: tACSParticipants in this group will receive transcranial alternating current stimulation (tACS) in addition to daily oral sertraline. tACS will be administered using the NEXALIN ADI device (Beijing Neslin Technology Co., Ltd.) with stimulation parameters set at a frequency of 77.5 Hz and a current intensity of 15 mA. One electrode will be placed on the forehead and two electrodes on the mastoid processes. Each session will last approximately 40 minutes, with a total of 20 sessions delivered across 4 consecutive weeks (5 sessions per week). The intervention is designed to modulate abnormal cortical oscillations, thereby alleviating depressive symptoms, enhancing cognitive performance, and supporting emotional regulation.
Sham	Sham comparator	Device: tACSArm Description: Participants in this group will receive sham stimulation in addition to daily oral sertraline. A sham device, identical in appearance, sound, and operation to the active tACS device, will be used but will not deliver any electrical current. Sessions will follow the same schedule as the active group (20 sessions over 4 weeks, 5 sessions per week). Both participants and operators will remain blinded to treatment allocation to maintain trial integrity.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tACSThis 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.	Device	tACS
tACSIn 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.	Device	Sham

Primary outcome

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)

8 secondary outcomes

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 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.
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.
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.
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.
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.
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.
Change in RSS (Ruminative Responses Scale)
Time frame: Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Results publication: PubMed 34029378Hetrick 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.
Results publication: PubMed 34969856Clancy 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.
Results publication: PubMed 35940423Jones 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.
Results publication: PubMed 30979801Yan 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.
Results publication: PubMed 37339227Chai 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.
Results publication: PubMed 38476648Wang 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.
Results publication: PubMed 37682331Biackova 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.
Results publication: PubMed 38880208Zhou 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.
Results publication: PubMed 33211157Elyamany 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.
Results publication: PubMed 26782765Bowes 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.
Results publication: PubMed 23497551Consoli 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.
Results publication: PubMed 25692174Hankin 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.

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Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xinyu Zhou contact

15823996993

zhouxinyu@cqmu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xinyu Zhou (15823996993, zhouxinyu@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07185464, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.