Major depressive disorder and bipolar disorder
Conditions
Interventions
High-frequency left prefrontal dTMS, 5 days per week, for 4 to 6 weeks
Sham stimulation, 5 days per week, for 4 to 6 weeks
Sponsors
Medical Care Toranomon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who does not respond to a return to work program 2)MDD or bipolar disorder 3)HDRS-21 score is not changed by 6 point or more after 6 weeks of treatment with fixed regimen of medication and/ or psychotherapy 4)Total HDRS-21 >=20 at baseline
Exclusion criteria
Exclusion criteria: 1)Enable to determine MT 2)Depression secondary to a general medical condition, or substance-induced 3)History of substance abuse or dependence within the past 6 months (except nicotine and caffeine) 4)Schizophrenic disorder or schizoaffective disorder 5)Major depression with psychotic features in the current episode 6)Individuals with a significant neurological disorder or insult including any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure, history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, mini Mental State Exam score of less than or equal to 24, Parkinson's disease, Huntington's chorea, multiple sclerosis) 7)Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness or personal history of epilepsy 8)Individuals with hearing loss 9)History of ECT treatment 10)Treatment with rTMS therapy 11)Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 3 years. 12)Any self-inflicted harm in the past 13)Implantation of metal object in upper body 14)Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease 15)Implanted neurostimulators 16)History of abnormal MRI 17)Women who are pregnant or breast-feeding 18)Clinically significant laboratory abnormality, in the opinion of the investigator based on CBC and biochemistry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total HDRS-21 score | — |
Secondary
| Measure | Time frame |
|---|---|
| The rates of response and remission, changes in cognitive function, and NIRS | — |
Countries
Japan
Contacts
Public ContactToshihide Hayashi
Medical Care Toranomon Medical Care Toranomon
Outcome results
None listed