RecruitingNot ApplicableNCT06728280

Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder

Efficacy and Safety of Deep Transcranial Magnetic Stimulation in Adolescent Major Depressive Disorder: a Prospective Double-Blind Randomized Controlled Trial

Sponsor

Zhifen Liu

Enrollment

100 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Diorder

Summary

The goal of this randomized controlled trial is to explore the efficacy and safety of two different dTMS devices in adolescent depression: deep TMS H1 coil and deep TMS H7 coil. The main questions it aims to answer are: Type of study: Clinical trial. Participant population: Adolescents with major depressive disorder (MDD). Objective: To explore whether the H7 coil is no less effective than the H1 coil for adolescents with MDD, further providing clinicians with additional treatment options for patients.

Eligibility

Min Age: 11 YearsMax Age: 23 Years

Inclusion Criteria5

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 Criteria8

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.