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Completed

NCT Number: NCT05577481

Neuronavigation Guided iTBS With Personalized Target for Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

XijingH

Xi'an, Shaan'xi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

sham iTBS combined with antidepressants

Combination Product

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

iTBS combined with antidepressants

Combination Product

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

Primary outcomes

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

    Time frame: baseline and 4-week 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.

Secondary outcomes

  1. Therapeutic response rate and remission rate

    Time frame: immediately post-treatment

    Response is defined as a reduction ≥ 50% on the HAMD-17 and remission is defined as a score <8 on the HAMD-17.

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

    Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment

    MADRS total score comprises a sum of the 10 individual item scores. Each item is rated on a 7 point scale from 0 to 6. The Total Score can range from 0 to 60, and higher scores indicate a greater degree of depression.

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

    Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment

    BSI-CV is a self-reported questionnaire with 19 items. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total score Scores of 0 - 16 indicate low risk for suicide and scores of 16 or greater indicate higher risk for suicide.

  4. Change in the Hamilton Anxiety Scale (HAMA) Score

    Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment

    HAMD total score comprises a sum of the 14 individual item scores. Each item is rated on a 5 point scale from 0 to 4. The Total Score can range from 0 to 56, and higher scores indicate a greater degree of anxiety.

  5. Change From Baseline Functional Connectivity to Immediately Post-treatment

    Time frame: baseline、immediately post treatment and 4-week post-treatment

    The change in resting state fMRI functional connectivity of the pgACC to the default mode network and within the default mode network will be assessed.

Other outcomes

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

    Time frame: Pre-treatment to immediately post-treatment

    The Perceived Deficits Questionnaire - Depression (PDQ-D) is a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression. The PDQ-D is a 20-item questionnaire and the total score ranger from 0 to 80, and higher scores indicate a greater degree of cognitive impairment. THINC-it® is a brief screening tool designed to measure cognition and determine whether cognitive functioning is impaired. Users can complete the cognitive screening in only 10-15 minutes. THINC-it® includes 4 objective cognitive tests (adapted from choice reaction time, 1-back working memory task, symbol digit coding, and Trails-B) and a subjective cognitive questionnaire (PDQ-5).

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2022
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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