Unique ID issued by UMIN | UMIN000024998 |
---|---|
Receipt number | R000028496 |
Scientific Title | Efficacy and safety of deep transcranial magnetic stimulation in treatment-resistant major depressive disorder and bipolar disorder: a randomized, double-blind, sham-controlled trial |
Date of disclosure of the study information | 2016/11/26 |
Last modified on | 2018/05/28 09:36:07 |
Efficacy and safety of deep transcranial magnetic stimulation in treatment-resistant major depressive disorder and bipolar disorder: a randomized, double-blind, sham-controlled trial
Efficacy and safety of dTMS in treatment-resistant MDD and BD
Efficacy and safety of deep transcranial magnetic stimulation in treatment-resistant major depressive disorder and bipolar disorder: a randomized, double-blind, sham-controlled trial
Efficacy and safety of dTMS in treatment-resistant MDD and BD
Japan |
Major depressive disorder and bipolar disorder
Psychiatry |
Others
NO
To examine the efficacy of deep TMS in patients with treatment-resistant depression or bipolar depression who does not respond to a return to work program
Safety,Efficacy
Change in the total HDRS-21 score
The rates of response and remission, changes in cognitive function, and NIRS
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Device,equipment |
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
25 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
40
1st name | |
Middle name | |
Last name | Shinsuke Kito |
National Center Hospital, National Center of Neurology and Psychiatry
Department of Psychiatry and Advanced Medical Technology
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
042-341-2711
kito@ncnp.go.jp
1st name | |
Middle name | |
Last name | Toshihide Hayashi |
Medical Care Toranomon
Medical Care Toranomon
1-16-16 Toranomon, Minatoku, Tokyo 105-0001, Japan
03-5510-3898
dtms@medcare-tora.com
Medical Care Toranomon
Medical Care Toranomon
Self funding
NO
2016 | Year | 11 | Month | 26 | Day |
Unpublished
No longer recruiting
2016 | Year | 11 | Month | 08 | Day |
2016 | Year | 11 | Month | 26 | Day |
2018 | Year | 10 | Month | 31 | Day |
2018 | Year | 10 | Month | 31 | Day |
2016 | Year | 11 | Month | 25 | Day |
2018 | Year | 05 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028496
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |