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NOT YET RECRUITING
NCT07369713
NA

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

Sponsor: First Affiliated Hospital of Chongqing Medical University

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder: A Randomized, Double-Blind, Controlled Pilot Study

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-08-01

Completion Date

2028-08-01

Last Updated

2026-03-04

Healthy Volunteers

No

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.

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China