Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients
- Conditions
- Treatment Resistant Depression
- 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
- 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 treatment refractory level and the further antidepressant efficacy of brain stimulation Baseline, Week 3 Maudsley staging method
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.
Trial Locations
- Locations (1)
Department of Psychiatry, Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
Department of Psychiatry, Taipei Veterans General Hospital🇨🇳Taipei City, Taiwan