Brain-derived Neurotrophic Factor and the Antidepressant Efficacy of Brain Stimulation
- Conditions
- Treatment Resistant Depression
- Interventions
- Device: Sham TBS-DLPFC or Sham rTMS-DLPFCDevice: Active iTBS-DLPFCDevice: Active rTMS-DLPFC
- Registration Number
- NCT04076124
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- Brief Summary
This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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 Sham TBS-DLPFC or Sham rTMS-DLPFC Sham TBS-DLPFC or Sham rTMS-DLPFC Patients in the sham group will receive the same iTBS or rTMS parameter stimulation, performing by a sham coil. Active iTBS-DLPFC Active iTBS-DLPFC This active group will receive intermittent theta-burst TMS stimulation. Active rTMS-DLPFC Active rTMS-DLPFC This active group will receive high-frequency repetitive TMS stimulation.
- Primary Outcome Measures
Name Time Method Percentage change in 17-item Hamilton Depression Rating Scale Baseline, Week 1, Week 2, Week 3, Week 4(day 20) 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 Response rate after 4-week treatment at the end of TMS sessions and three month after. Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80) improvement \> 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
Changes in Clinical Global Index Baseline, Week 1, Week 2, Week 3, Week 4(day 20) Clinical Global Index
The association between the value pf baseline Life event stress scale and the antidepressant efficacy of brain stimulation Baseline, Week 4(day 20) Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Changes in EEG band before and after brain stimulation Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment) Perform rACC-engaging cognitive task(RECT) before 1-st treatment
Changes in depression severity, rated by self-reported Baseline, Week 1, Week 2, Week 3, Week 4(day 20) Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.
Changes in Young Mania Rating Scale Baseline, Week 1, Week 2, Week 3, Week 4(day 20) Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.
The association between BDNF Polymorphism genotype and the antidepressant efficacy of brain stimulation Baseline, Week 4(day 20) Val/Val, Met/Met, Val/Met genotype and the efficacy after receiving 4-week treatment. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale
The association between the value of baseline brain metabolism and the antidepressant efficacy of brain stimulation Baseline, Week 4(day 20) baseline PET/MRI.The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
The association between the value of Baseline treatment refractory level and the antidepressant efficacy of brain stimulation Baseline, Week 4(day 20) Maudsley staging method. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Remission rate after 4-week treatment Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80) 17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)
Trial Locations
- Locations (1)
Department of Psychiatry, Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan