Neuronavigation Guided iTBS With Personalized Target for Depression

NCT05577481 | Completed Phase 2

• 1 other identifier: XJLL-KY20222111
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

depression; intermittent Theta Burst Stimulation; neuronavigation

Outcome Measures

Primary Outcomes (1)

• Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment

  The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.

  baseline and 4-week post treatment

Secondary Outcomes (5)

• Therapeutic response rate and remission rate

  immediately post-treatment

• Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

  baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment

• Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score

  baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment

• Change in the Hamilton Anxiety Scale (HAMA) Score

  baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment

• Change From Baseline Functional Connectivity to Immediately Post-treatment

  baseline、immediately post treatment and 4-week post-treatment

Other Outcomes (1)

• Change in a Neuropsychological Test Battery from Baseline to immediately post-treatment

  Pre-treatment to immediately post-treatment

Study Arms (2)

functional MRI-guided iTBS(sham group)

SHAM COMPARATOR

The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).

Combination Product: sham iTBS combined with antidepressants

functional MRI-guided iTBS (pgACC-DLPFC)

EXPERIMENTAL

The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).

Combination Product: iTBS combined with antidepressants

Interventions

sham iTBS combined with antidepressants COMBINATION_PRODUCT

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

functional MRI-guided iTBS(sham group)

iTBS combined with antidepressants COMBINATION_PRODUCT

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

functional MRI-guided iTBS (pgACC-DLPFC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years old
• Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
• Meet the threshold on the total HAMD17 score of \>17 at both screening and baseline visits
• Able to provide informed consent

You may not qualify if:

• any other current or past psychiatric axis-I or axis-II disorders
• severe physical illnesses
• psychotic symptoms, alcohol or drug abuse
• A history of neurological disorders including seizure, cerebral trauma
• MRI evidence of structural brain abnormalities
• Contraindications to MRI and rTMS
• Acute suicide
• Female that is pregnant or breastfeeding

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

XijingH

Xi'an, Shaan'xi, 710032, China

Location

Related Publications (2)

• Zheng K, Chen L, Wang H; DIRECT consortium; Li B, Chen B. Beyond depression symptoms: the default mode network as a predictor of antidepressant response. Npj Ment Health Res. 2026 Jan 16;5(1):2. doi: 10.1038/s44184-025-00182-2.

  PMID: 41545765 DERIVED

• Liu N, Zhao N, Tang N, Cai M, Zhang Y, Lv R, Zhang Y, Han T, Meng Y, Zang Y, Wang H. Safety and efficacy of individual target transcranial magnetic stimulation to stimulate the most negative correlate of DLPFC-pgACC in the treatment of major depressive disorder: study protocol of a double-blind, randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e081520. doi: 10.1136/bmjopen-2023-081520.

  PMID: 39515856 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 13, 2022
• Study Start: July 10, 2023
• Primary Completion: January 30, 2025
• Study Completion: February 28, 2025
• Last Updated: April 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)