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Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder

NCT07369713 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-04

No results posted yet for this study

Summary

This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Accelerated Intermittent Theta-burst Stimulation (a-iTBS) intervention for adolescent depression through a pilot clinical trial. The findings will inform the design and optimization of subsequent formal randomized controlled trials, providing essential evidence for their execution.

Conditions

  • Depression - Major Depressive Disorder

Interventions

DEVICE

Experimental target a-iTBS treatment

Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site.

DEVICE

Conventional target a-iTBS treatment

Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site.

DEVICE

Sham stimulation treatment

Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output.

Sponsors & Collaborators

  • First Affiliated Hospital of Chongqing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2028-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369713 on ClinicalTrials.gov