Evaluating deep TMS devices for treating adolescent depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.