NCT06728280

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Zhifen Liu · Academic / Other
• Sex: All
• Age: 11 Years – 23 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Transcranial magnetic stimulation (TMS) is a safe and well-tolerated intervention that has been extensively studied as a treatment for MDD. However, little is known about the effectiveness of deep transcranial magnetic stimulation (dTMS) in adolescents with major depressive disorder (MDD). Only one open-label trial tested dTMS using H1 coils in adolescents with treatment-resistant depression, the results showed that the severity of depressive symptoms was significantly reduced after treatment, with a response rate of 42%. Hence, the continued efforts are needed to improve and optimize these treatments. One important factor that influence the efficacy of TMS was the seletion of stimulation target. In recent years, medial prefrontal cortex (MPFC) and anterior cingulate cortex (ACC) have recently been considered promising alternative targets for treatment of adolescents with MDD, due to their association with reward, emotion, mood, and habits. Additionally, the stimulation target for dTMS with the H7 coil is the MPFC. Current relevant clinical studies show that after dTMS intervention using the H7 coil, depressive symptoms and overall clinical impressions in adults with MDD are significantly improved. However, whether alternative strategies for TMS treatment (e.g., H1 coil versus H7 coil) are more effective in adolescents with MDD remains unknown. The purpose of this randomized controlled trial is to evaluate the efficacy and safety of two different dTMS devices (H1 coil and H7 coil) in the treatment of adolescent with MDD, further providing clinicians with additional treatment options for patients.

Conditions

• Major Depressive Diorder

Interventions

Type	Name	Description
DEVICE	deep transcranial magnetic stimulation with H1coil	Participants will receive dTMS treatment with H1 coil
DEVICE	deep transcranial magnetic stimulation with H7 coil	Participants will receive dTMS treatment with H7 coil

Timeline

• Start date: 2024-12-31
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-12-11
• Last updated: 2025-03-12

Locations

2 sites across 1 country: China