Actively Recruiting

Phase Not Applicable
Age: 11Years - 23Years
All Genders
NCT06728280

Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder

Led by Zhifen Liu · Updated on 2025-03-12

100

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder

Who Can Participate

Age: 11Years - 23Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of all genders, aged between 11 and 23 years old, and right-handed
  • Diagnosed with major depressive disorder according to DSM-5 criteria
  • Current major depressive episode confirmed by Mini International Neuropsychiatric Interview (M.I.N.I)
  • Beck Depression Inventory-II (BDI-II) score greater than 13 at screening
  • Able and willing to understand and follow the clinical trial protocol and provide informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of other psychiatric disorders according to DSM-5
  • Significant laboratory abnormalities or medical conditions that may interfere with study participation
  • History of significant neurological diseases such as subdural hematoma, brain tumor, seizure/epilepsy, or major head trauma
  • Suicide risk or suicidal behavior within 6 months before screening
  • Previous treatment with electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct or alternating current stimulation
  • Contraindications to MRI or TMS, such as metal implants or electronic devices
  • Participation in any investigational drug trial within 6 months before baseline visit
  • Any other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, China, 030001

Actively Recruiting

2

Deep Transcranial Magnetic Stimulation

Taiyuan, Shanxi, China, 030012

Actively Recruiting

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Research Team

Z

Zhifen Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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