Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder

NCT ID: NCT06728280

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

H1 coil

First, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H1 coil was advanced 6 cm anterior to the scalp surface.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over the left dorsolateral prefrontal cortex.

Group Type: ACTIVE_COMPARATOR

deep transcranial magnetic stimulation with H1coil

Intervention Type: DEVICE

Participants will receive dTMS treatment with H1 coil

H7 coil

First, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H7 coil was advanced 4 cm anterior to 'hot spot' and aligned symmetrically over the dmPFC. The rMT was rechecked at least once a week.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over themedial prefrontal cortex.

Group Type: EXPERIMENTAL

deep transcranial magnetic stimulation with H7 coil

Intervention Type: DEVICE

Participants will receive dTMS treatment with H7 coil

Interventions

deep transcranial magnetic stimulation with H1coil

Participants will receive dTMS treatment with H1 coil

Intervention Type: DEVICE

deep transcranial magnetic stimulation with H7 coil

Participants will receive dTMS treatment with H7 coil

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhifen Liu

OTHER

Sponsor Role: lead

Responsible Party

Zhifen Liu

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, China

Site Status: RECRUITING

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhifen Liu

Role: CONTACT

zhifenliu@sxmu.edu.cn

+8613703586547

Facility Contacts

Zhifen Liu

Role: primary

zhifenliu@sxmu.edu.cn

86+13703586547

zhifen ZF Liu

Role: primary

zhifenliu@sxmu.edu.cn

+8613703586547

Other Identifiers

NO.KYLL-2024-001

Identifier Type: -

Identifier Source: org_study_id