Evaluating deep TMS devices for treating adolescent depression
Efficacy and Safety of Deep Transcranial Magnetic Stimulation in Adolescent Major Depressive Disorder: a Prospective Double-Blind Randomized Controlled Trial
This study is testing two different devices to see which one works better for treating depression in teenagers aged 11 to 23.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 11 Years to 23 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Shanxi Medical University Academic / other |
| Locations | 2 sites (Taiyuan, Shanxi and 1 other locations) |
| Trial ID | NCT06728280 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of two different deep transcranial magnetic stimulation (dTMS) devices, the H1 coil and the H7 coil, in treating adolescents with major depressive disorder (MDD). The study will involve adolescents aged 11 to 23 who meet the diagnostic criteria for MDD, and will compare the effectiveness of the two coils in reducing depressive symptoms. Participants will undergo treatment with either device, and their progress will be monitored to determine which coil may offer better outcomes. The trial seeks to provide clinicians with additional treatment options for adolescent patients suffering from depression.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 11 to 23 who have been diagnosed with major depressive disorder.
Not a fit: Patients with other psychiatric disorders or significant neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for adolescents suffering from major depressive disorder.
How similar studies have performed: Previous studies have shown promising results with dTMS in adults, but this specific comparison in adolescents is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of all genders, aged between 11 and 23 years old, and right-handedness. * In accordance with the diagnostic criteria for the major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). * The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (M.I.N.I). * Beck Depression Inventory, Second Edition (BDI-II): total BDI-II score\> 13 at screening. * Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent. Exclusion Criteria: * A diagnosis of other psychiatric disorders in the DSM-5. * Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing the procedures required by the study. * History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure/epilepsy disorder, or history of significant head trauma. * Have obvious suicide risk, or have actual suicide behavior within 6 months before the screening. * History of treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial Direct Current Stimulation (tDCS), or transcranial Alternating Current Stimulation (tACS) treatments for any disorders. * There are contraindications to magnetic resonance imaging (MRI) scanning or TMS treatment, such as metal or electronic instruments. * Participation in any investigational drug trial within 6 months before the baseline visit. * Other conditions that are not suitable for the study object in the researcher's judgment.
Where this trial is running
Taiyuan, Shanxi and 1 other locations
- Deep Transcranial Magnetic Stimulation — Taiyuan, Shanxi, China (Recruiting)
- Deep Transcranial Magnetic Stimulation — Taiyuan, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Zhifen Liu
- Email: zhifenliu@sxmu.edu.cn
- Phone: +8613703586547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.