Depression - Major Depressive Disorder
Conditions
Brief 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 effects in both the intervention and control groups, ensuring the safety and tolerability of tACS in adolescent populations.
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.
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 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CDRS-R (Children's Depression Rating Scale) scores from baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | Improvement in anxiety (SCARED minus the scores） |
| Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale) | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | The severity of the suicide risk |
| Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | Improvement in sleep status (PSQI minus the scores） |
| Change in BDI-II (Baker Depression Scale) scores from baseline | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | Change in BDI-II (Baker Depression Scale) scores from baseline |
| Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | Improvement in overall clinical impression severity ( 7-point scale, with 1 being normal and 7 being among the most severely damaged ) |
| Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | Improvement of clinical general Impression scale (7-point scale,7 denoting a very significant deterioration) |
| Change in RSS (Ruminative Responses Scale) | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | The level of improvement in negative thinking(the higher the total score, the more reflective thinking the more severe it is). |
| Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline | Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months. | Improvement of children's quality of life（PedsQL4.0 minus the scores) |
Countries
China
Contacts
Primary ContactXinyu Zhou
Outcome results
None listed