Depression
Conditions
Keywords
depression, intermittent Theta Burst Stimulation, neuronavigation
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.
Interventions
COMBINATION_PRODUCTsham iTBS combined with antidepressants
Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
COMBINATION_PRODUCTiTBS combined with antidepressants
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic response rate and remission rate | 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. |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score | 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. |
| 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 | 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. |
| Change in the Hamilton Anxiety Scale (HAMA) Score | 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. |
| Change From Baseline Functional Connectivity to Immediately Post-treatment | 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. |
Countries
China
Outcome results
None listed