The evidence so far suggests that inhibitory function, such as GABAa-receptor-related and GABAb-receptor-related inhibitory function in the DLPFC, is key to treatment responses in MDD. Prolonged intermittent theta-burst stimulation(piTBS) could be effective through the modulation of prefrontal excitatory and inhibitory function. In addition, previous literature provided the evidence that 2-weeks left-sided DLPFC-piTBS had similar antidepressant efficacy with the 4-6weeks standard left-sided DLP
Conditions
Interventions
Group A (piTBS group): A three-pulse 50Hz wave delivered every 200ms at 80% active motor threshold, with stimulation for 2 seconds followed by an 8-second rest, for 60 cycles, totaling 1800 pulses/ses
Sponsors
Taipei Veterans General Hospital, Taipei, Taiwan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The diagnosis of recurrent MDD is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (American Psychiatric Association, 1994). Patients qualified to participate in the study if they failed to respond to at least 1 adequate antidepressant treatment for their current episode (e.g., failed to achieve 50% improvement in depression to an equivalent daily dose of 10-20 mg of escitalopram for at least 8 weeks). MDD patients would be recruited only if the score of the 17-item Hamilton Depression Rating Scale (HDRS-17) is 18 or more and the score of a Clinical Global Impression Severity is 4 or more. All participants were on stable antidepressant regimens or no antidepressant therapy for at least 4 weeks prior to this trial.
Exclusion criteria
Exclusion criteria: (1)A lifetime psychiatric diagnosis of psychotic disorder, bipolar disorder, organic mental disorder, substance use disorder (based on DSM-IV criteria), and a lifetime medical history of major systemic illness and neurological disorder records(e.g., seizure, cerebrovascular disease, stroke, meningitis and traumatic brain injury) (2)A history of brain surgery, brain implants (e.g., neurostimulators, clip), and cardiac pacemakers and any mental device or implant in the body (e.g. neurostimulators, electrodes, cochlear implant) (3)Any major brain organic insults (e.g., brain arteriovenous malformation, cerebral aneurysm, primary or secondary tumors in central nervous system) (4)Having active suicidal intent, or high suicidality if score of the third item of HDRS-17 is 4 in recent one week. (5)Women in pregnancy. (6)Claustrophobia: people cannot stay in a closed environment (e.g., MRI scan) (7)Presence of any other condition that has the potential to prevent study completion or may confound the outcome assessments (e.g. refusal to sign the informed consent, no meet the inclusion criteria after recruitment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in depression severity, measured by a percentage change in 17-items Hamilton Depression Rating Scale(HDRS-17) score (% HDRS-17) before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The response rate (defined as a >= 50% reduction compared with the baseline HDRS-17 score) and the remission rate (defined as an HDRS-17 score <= 7). 2. Safety 3. the changes of TMS-EEG parameters before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham) 4. the changes of regional brain glucose metabolism before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham) 5. the changes of prefrontal EEG before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham) 6. the changes of cognitive function, measured by Test of Attentional Performance and Go-Nogo test, before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham) 7. the changes of functional connectivities before and after 4 weeks of brain stimulation treatment between the three groups (piTBS,10HzrTMS and sham) 8. the correlation between antidepressant efficacy and baseline prefrontal function, measured by EEG, TMS-EEG indices and glucose metabolism and functional connectivities and EEG. 9. the correlation between antidepressant efficacy and baseline mood-related brain area, measured by glucose metabolism and functional connectivities. 10. the correlation between antidepressant efficacy and the changes of glucose metabolism and functional connectivities on the mood-related brain area. 11. the correlation between antidepressant efficacy and the changes of TMS-EEG and EEG indices on prefrontal cortex. 12. the correlation between antidepressant efficacy and patients' characteristic (e.g., treatment refractoriness) | — |
Countries
Asia(except Japan)
Contacts
Public ContactCheng-Ta Li
Taipei Veterans General Hospital, Taipei, Taiwan Department of Psychiatry
Outcome results
None listed