CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
sham iTBS combined with antidepressants +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05577481
NCT05577481Phase 2Completed

Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder

Xijing Hospital·interventional·Posted Oct 13, 2022·Updated Apr 27, 2026

In Brief

A Phase 2 clinical trial evaluating sham iTBS combined with antidepressants and iTBS combined with antidepressants for Depression. Completed, enrolled 68 participants across 1 site.

Detailed Summary

The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedOct 13, 2022
Enrollment StartJul 10, 2023
Primary CompletionJan 30, 2025
Study CompletionFeb 28, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.7 years ago

Interventions

sham iTBS combined with antidepressantscombination

Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.

iTBS combined with antidepressantscombination

Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.