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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a brain stimulation technique called Deep Transcranial Magnetic Stimulation (DTMS) in adolescents and young adults with major depression. DTMS uses magnetic pulses delivered through a helmet-like device to stimulate specific brain regions and reduce depression symptoms — without surgery or medication. **You may be eligible if...** - You are between 11 and 23 years old and right-handed - You have been diagnosed with major depressive disorder (MDD) based on DSM-5 criteria - A formal evaluation (using the MINI interview) confirmed your current depressive episode - You scored above 13 on the Beck Depression Inventory (BDI-II) - You are willing to follow the study protocol and can sign (or have a guardian sign) consent **You may NOT be eligible if...** - You have another psychiatric diagnosis - You have a significant neurological condition (brain tumor, seizures, severe head injury) - You have an active high risk of suicide or a suicide attempt in the past 6 months - You have previously received TMS, ECT, tDCS, or tACS treatment - You have metal implants or electronic devices in your body (which are incompatible with magnetic stimulation) - You participated in a drug trial in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEdeep transcranial magnetic stimulation with H1coil

Participants will receive dTMS treatment with H1 coil

DEVICEdeep transcranial magnetic stimulation with H7 coil

Participants will receive dTMS treatment with H7 coil


Locations(2)

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, China

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, China

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NCT06728280


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