A treatment option for Medication-resistant depression
Conditions
Interventions
Left DLPFC prolonged intermittent TBS group (2 session/day, 5 days/week, 2 weeks)
80% active motor threshold, 1800 pulses/session.
Left DLPFC 10Hz rTMS group (2 session/day, 5 days/week,2-weeks)
120% motor threshold,3000 pulses/session
Sham group(2 session/day, 5 days/week,2 weeks) randomly divided to half with TBS and half with rTMS parameters using a sham coil.
Sponsors
Grant of Taipei Veterans General Hospital, Taiwan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were qualified (1) if they failed to respond to at least one adequate antidepressant treatment in their current episode. (2) The recruited patients were required to be antidepressant-free for at least 2 weeks prior to this double-blind, sham-controlled trial (if fluoxetine uses, the antidepressant-free period needs to be 4 weeks). (3) Moreover, all recruited participants had to 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.
Exclusion criteria
Exclusion criteria: Patients were excluded if (1) they had a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria) (2) or probable dementia diagnosis based on a Mini Mental Status Exam (MMSE) score of <26 and clinical evidence of dementia.(3) People with a lifetime medical history of major systemic illness and neurological disorder records (e.g., stroke, seizure, (4) traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers, and (5) pregnant women were also excluded. (6) regarding to potential safety issues during the monotherapy period of brain stimulation, patients with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17) (7)receiving bupropion >300 mg/day due to dose-dependent increased risk of seizures, or receiving lorazepam >2 mg/day or any anticonvulsant due to reduced cortical excitability which may interfere with rTMS efficacy were excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome was improvement in depression, measured by percentage change in HDRS-17 score (% HDRS-17) before and after 2 weeks of brain stimulation treatment between the prolonged intermittent theta-burst stimulation, 10Hz-repetitive transcranial magnetic stimulation, and sham control. | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes among three groups(pretreatment vs posttreatment) in (1) response rate (defined as >=50% reduction compared with the baseline HDRS-17 score) and (2) the remission rate (defined as HDRS-17 score <8).(3)Computerized rACC-engaging cognitive task(RECT)and EEG bands (4)functional changes of PET/MRI (5) Neurocognitive tests for attentional performance (TAP) and executive function (Wisconsin card sorting test). (6) TMS-EEG (7) genome-wide association evaluation. (8) DSSS scale, and CGI. | — |
Countries
Asia(except Japan)
Contacts
Public ContactCheng-Ta Li
Taipei Veterans General Hospital, Taiwan Department of Psychiatry
Outcome results
None listed