Depression - Major Depressive Disorder
Conditions
Brief 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. The study will also explore changes in clinical symptoms, cognitive performance, and brain function following the intervention.
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.
Interventions
DEVICEtACS
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.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age 12-18 years. 2. Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL. 3. Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline. 4. Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.
Exclusion criteria
1. Psychiatric comorbidities other than anxiety disorders. 2. Depression with psychotic features. 3. Young Mania Rating Scale (YMRS) score \>13. 4. 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). 5. Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies. 6. Current use of antiepileptic drugs or high-dose benzodiazepines. 7. History of alcohol or substance abuse or dependence. 8. Pregnant or breastfeeding females. 9. Contraindications to MRI. 10. Current high suicide risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility (Number of Participants Enrolled) | From the start of recruitment to completion of enrollment, up to 2 years | 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. |
| Intervention adherence (number of participants who completed the full 20 treatment sessions) | End of treatment at Week 4 | 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. |
| Retention Rate (Number of Participants Remaining at 16-Week Follow-up) | From randomization through the final follow-up assessment at Week 16 | 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. |
| Incidence of Adverse Events and Serious Adverse Events | From the first stimulation session through the final follow-up assessment at Week 16 | 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. |
Countries
China
Contacts
CONTACTXinyu Zhou
Outcome results
None listed