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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
XijingH
Xi'an, Shaan'xi, China
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.
Time frame: baseline and 4-week post treatment
Therapeutic response rate and remission rate
Response is defined as a reduction ≥ 50% on the HAMD-17 and remission is defined as a score \<8 on the HAMD-17.
Time frame: immediately post-treatment
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
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.
Time frame: 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
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.
Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
Change in the Hamilton Anxiety Scale (HAMA) Score
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.
Time frame: baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change From Baseline Functional Connectivity to Immediately 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.
Time frame: baseline、immediately post treatment and 4-week post-treatment