Individuals with major depressive disorder with failure to achieve satisfactory improvement from previous antidepressant medication treatment using standardized criteria based on the European Group for the Study of Resistant Depression (GSRD). Major depressive disorder Antidepressant failure Deep TMS Non-inferiority Trail
Conditions
Interventions
Deep TMS using H-1 coil (Brainsway'
s model 104) emitting magnetic waves to non-invasively stimulate the left dorsolateral prefrontal cortex. Sessions are scheduled thrice weekly. The parameters are a frequency of 18 Hz, 120% intensity
Experimental Device,Active Comparator Device
3 sessions per week ,5 sessions per week
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 68 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-68 year-old 2.Principal diagnosis of Major Depressive Disorder, confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Thai version 3.Psychiatric comorbidities are allowed if they are not the principal diagnosis. 4.CGI-S 4 and over (Indicating that the illness is of at least moderate severity with impairment in at least two settings) 5.MADRS 20 and over(Indicating that the depressive disorder is of at least moderate severity) 6.Failed to achieve satisfactory improvement from previous antidepressant medication treatment using standardized criteria 7.Psychotropic medications can remain unchanged during the 4 weeks of dTMS. 8.Ability to self-administer OR provide answers to the questionnaire sufficiently.
Exclusion criteria
Exclusion criteria: 1.Evidence of psychotic features in the current major depressive episode (MDE) 2.Lifetime history of bipolar disorder and psychotic disorder. 3.Substance dependence or misuse 3 months and under before to the study entry 4.History of electroconvulsive therapy, repetitive transcranial magnetic stimulation, ketamine infusion, or Esketamine treatment within the past 3 months prior to partaking in the study 5.Currently taking Bupropion over 300 mg-day 6.Currently taking anticonvulsants (except for lorazepam 2 mg and under-day) 7.8Q score of 17 and over (Indicating a high risk of suicide prompting hospitalization) at any point of time in the study period 8.Significant neurological disorder or insult, including, but not limited to, uncontrolled epilepsy, previous significant head injuries or brain surgeries 9.Metal objects within or near the head e.g cochlear implant or cortical stimulator or deep brain stimulator, ventriculoperitoneal shunt (excluding objects in the mouth that cannot be safely removed) 10.Cardiac pacemaker AND-OR implanted electronic devices 11.Pregnancy AND-OR lactation (based on history of menstruation and contraception) 12.Significant medical comorbidities 13.Inability to commute to the King Chulalongkorn Memorial Hospital for 5 days per week for 4 consecutive weeks 14.Impairment in decisional capacity to participate in the study (e.g. those with a documented intellectual disability or major neurocognitive disorder, actively psychotic, or actively manic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms At the end of acourse course (12 or 20 sesions) MADRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Depressive symptoms At 16 and 24 weeks MADRS,Safety Every session. AE/SAE,Practicality At the end of acourse course (12 or 20 sesions) Qualitative analysis of feaasibility, acceptability, adherence facilitators and barriers | — |
Countries
Thailand
Contacts
Public ContactChanatip Tongyonk
King Chulalongkorn Memorial Hospital, Thai Red Cross Society
Outcome results
None listed