The evidence so far suggests that inhibitory function, especially GABAb-receptor-related LICI in the DLPFC, is key to treatment responses in MDD. iTBS could be effective through the modulation of prefrontal inhibitory function. However, the following questions remain to be answered: (1) the potentially different effects of iTBS and rTMS on PFC inhibitory functions, and (2) the identification of reliable biomarkers, including EEG signals, that could reliably predict the antidepressant effects of
Conditions
Interventions
Group A (iTBS group): A three-pulse 50Hz wave is delivered every 200ms at 80% AMT (light fist clench), with stimulation for 2 seconds followed by an 8-second rest, for 60 cycles, totaling 1800 pulses,
Sponsors
Taipei Veterans General Hospital, Taipei, Taiwan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We aim to recruit 60 MDD patients (10 patients randomly assigned to the sham group) and 20 healthy participants aged 21 to 70 years. MDD patients: The diagnosis of recurrent MDD is based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. Diagnoses are established after taking a thorough medical history and conducting a semistructured interview using the Mini International Neuropsychiatric Interview (MINI) (American Psychiatric Association, 1994). MDD patients are recruited only if their 17-item Hamilton Depression Rating Scale (HDRS-17) score is greater than 18, and their Clinical Global Impressions-Severity (CGI-S) score is greater than 4. Patients qualify to participate in the study if they have failed to respond to at least one adequate antidepressant treatment for their current episode (e.g., failed to achieve a 50% improvement in depression). All subjects are required to be antidepressant-free for at least 1 week before the study (excluding those taking fluoxetine within one month). Healthy participants: Healthy control subjects must be free from any DSM-IV diagnosis after the MINI interview at baseline.
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), or a lifetime medical history of major systemic illness and neurological disorder (e.g., seizure, cerebrovascular disease, stroke, meningitis, traumatic brain injury). 2. A history of brain surgery, brain implants (e.g., neurostimulators, clips), cardiac pacemakers (e.g., TCP), or any metal device or implant in the body (e.g., neurostimulators, electrodes, cochlear implants). 3. Any major brain organic insults (e.g., brain arteriovenous malformation, cerebral aneurysm, primary or secondary tumors in the central nervous system). 4. Having active suicidal intent or high suicidality, indicated by a score of 4 on the third item of the HDRS-17 in the past week. 5. Women who are pregnant or lactating. 6. Claustrophobia: inability to stay in a closed environment (e.g., MRI scan). 7. Subjects who need to take any drugs that may pose a risk of epilepsy. 8. Presence of any other condition that has the potential to prevent study completion or may confound outcome assessments (e.g., refusal to sign the informed consent, failure to meet inclusion criteria after recruitment). 9. Having received fluoxetine treatment within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome was improvement in depression, measured by a percentage change in HDRS-17 score (% HDRS-17) before and after 2 weeks of brain stimulation treatment between the three groups. | — |
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. Relationships between EEG variables and LICI improvement. | — |
Countries
Asia(except Japan)
Contacts
Public ContactCheng-Ta Li
Taipei Veterans General Hospital, Taiwan Department of Psychiatry
Outcome results
None listed