Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder

NCT06728280 | Recruiting

• 1 other identifier: NO.KYLL-2024-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Diorder

Keywords

deep transcranial magnetic stimulation; Major Depressive Diorder; adolescents

Outcome Measures

Primary Outcomes (3)

• Hamilton Depression Scale -24 (HAMD-24)

  score change. Higher score means worse outcome.(Min = 0, Max = 76)

  From enrollment to the end of treatment at 12 weeks

• Response on Hamilton Depression Scale-24

  Defined as a score reduction of 50% or more

  From enrollment to the end of treatment at 12 weeks

• Remission onHamilton Depression Scale-24

  Defined as a score of 7 or less

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (9)

• Hamilton Anxiety Rating Scale (HAM-A)

  From enrollment to the end of treatment at 12 weeks

• Snaith-Hamilton Pleasure Scale (SHAPS)

  From enrollment to the end of treatment at 12 weeks

• Beck Scale for Suicide Ideation-Chinese Version (BSI-CV)

  From enrollment to the end of treatment at 12 weeks

• Self-Injury Diary Card

  From enrollment to the end of treatment at 12 weeks

• Pittsburgh sleep quality index(PSQI)

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

H1 coil

ACTIVE COMPARATOR

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.

Device: deep transcranial magnetic stimulation with H1coil

H7 coil

EXPERIMENTAL

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.

Device: deep transcranial magnetic stimulation with H7 coil

Interventions

deep transcranial magnetic stimulation with H1coil DEVICE

Participants will receive dTMS treatment with H1 coil

H1 coil

deep transcranial magnetic stimulation with H7 coil DEVICE

Participants will receive dTMS treatment with H7 coil

H7 coil

Eligibility Criteria

• Age: 11 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhifen Liu: lead

Study Sites (2)

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, 030001, China

RECRUITING

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, 030012, China

RECRUITING

Central Study Contacts

Zhifen Liu

CONTACT

+8613703586547; zhifenliu@sxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Given the study's design, blinding TMS operators will not be possible. Still, participants、staff responsible for participant assessments and data analysis will be blinded to treatment conditions and external to the clinic staff. Patients will be instructed not to reveal their group assignment to the raters. Patients will not be given the specifics of the treatment parameters and will be instructed not to talk to each other during the study period. Both treatments will be presented as effective to them. Lastly, the data management center will strictly control access to the randomization code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: randomized, double-blind,single-center, two-arm, parallel-group superiority trial

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 31, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)