Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients
- Conditions
- Treatment Resistant Depression
- Interventions
- Device: Active high-dosage iTBS-DMPFCDevice: Active standardized iTBS-DMPFCDevice: Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC
- Registration Number
- NCT04037592
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- Brief Summary
This study evaluates an association between different dosage and the antidepressant efficacy of theta burst stimulation in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e. standardized dosage intermittent theta-burst stimulation treatment, high dosage intermittent theta-burst stimulation treatment or sham treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- Male or female, 21 to 70 years of age.
- Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)
- Participants failed to respond to at least one adequate antidepressant treatment in their current episode
- Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)
- Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.
- Participants also failed to respond to one complete left-sided DLPFC 10Hz rTMS/piTBS treatment course.
- a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)
- Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.
- Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers
- Women with breastfeeding or pregnancy
- Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active high-dosage iTBS-DMPFC Active high-dosage iTBS-DMPFC This active group will receive high dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC) Active standardized iTBS-DMPFC Active standardized iTBS-DMPFC This active group will receive standardized dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC) Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC Patients in the sham group will receive the same standardized or high-dosage iTBS performing by a sham coil
- Primary Outcome Measures
Name Time Method Percentage change in 17-item Hamilton Depression Rating Scale Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation) the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
- Secondary Outcome Measures
Name Time Method the change of brain connectivity after 3-week iTBS treatment Baseline, Week 3 the change in brain connectivity
Response rate after 3-week treatment at the end of iTBS sessions and three and six month after. Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation) improvement \> 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
Changes in depression severity, rated by self-reported Baseline, Week 1, Week 2, Week 3 Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.
Baseline single-pulse stimulation and the further antidepressant efficacy of brain stimulation Baseline, Week 3 baseline single-pulse stimulation
Remission rate after 3-week treatment Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation) 17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)
Changes in Young Mania Rating Scale Baseline, Week 1, Week 2, Week 3 Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.
Baseline brain connectivity and the further antidepressant efficacy of brain stimulation Baseline, Week 3 baseline functional MRI
Changes in EEG band before and after brain stimulation Day 1(pre-RECT, post RECT, post 1st treatment, pre-30th treatment) Perform rostral anterior cingulate cortex(rACC)-engaging cognitive task(RECT) before 1-st treatment
Baseline paired-pulse stimulation and the further antidepressant efficacy of brain stimulation Baseline, Week 3 baseline paired-pulse stimulation
Changes in Clinical Global Index Baseline, Week 1, Week 2, Week 3 Clinical Global Index
Baseline Life event stress scale and the further antidepressant efficacy of brain stimulation Baseline, Week 3 Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress.
Changes in single-pulse stimulation before and after brain stimulation Baseline, Week 3 the change in single-pulse stimulation
Changes in paired-pulse stimulation before and after brain stimulation Baseline, Week 3 the change in paired-pulse stimulation
Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale Baseline, Week 1, Week 2, Week 3 the altered anxiosomatic cluster symptoms (range, 0 to 26, with higher scores indicating more severe anxiosomatic symptoms).The anxiosomatic cluster symptoms comprised nine items derived from HDRS-17: early insomnia, middle insomnia, slowness or retardation, psychic anxiety, autonomic anxiety, gastrointestinal symptoms, somatic symptoms, genital symptoms, and hypochondriasis.
Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation Baseline, Week 3 Maudsley staging method
Trial Locations
- Locations (1)
Department of Psychiatry, Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan