Treatment Resistant Depression
Conditions
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.
Interventions
DEVICEActive rTMS-DLPFC
Participants in the rTMS active stimulation group will receive 4-week 10 Hz 120% of RMT to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
DEVICEActive iTBS-DLPFC
Participants in the intermittent TBS(iTBS) active stimulation group will receive 4-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
DEVICESham TBS-DLPFC or Sham rTMS-DLPFC
Half of the patients in the sham group received 4-week the same iTBS parameter stimulation (sham-iTBS), and the other half received the same rTMS parameter stimulation using a sham coil (sham-rTMS), which also improved the blinding process.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Changes in Clinical Global Index | Baseline, Week 1, Week 2, Week 3, Week 4(day 20) | Clinical Global Index |
| 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. |
| 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) |
| 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. |
| 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 |
| 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 |
Countries
Taiwan
Contacts
Primary ContactCheng-Ta Li, Professor
Outcome results
None listed