Unique ID issued by UMIN | UMIN000032313 |
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Receipt number | R000036832 |
Scientific Title | Efficacy and safety of repetitive transcranial magnetic stimulation with new protocol in treatment-resistant major depressive disorder and bipolar disorder: a randomized, open-label, parallel group trial |
Date of disclosure of the study information | 2018/04/25 |
Last modified on | 2019/03/15 18:00:10 |
Efficacy and safety of repetitive transcranial magnetic stimulation with new protocol in treatment-resistant major depressive disorder and bipolar disorder: a randomized, open-label, parallel group trial
Efficacy and safety of rTMS with new protcol in treatment-resistant MDD and BD
Efficacy and safety of repetitive transcranial magnetic stimulation with new protocol in treatment-resistant major depressive disorder and bipolar disorder: a randomized, open-label, parallel group trial
Efficacy and safety of rTMS with new protcol in treatment-resistant MDD and BD
Japan |
Major depressive disorder and bipolar disorder
Psychiatry |
Others
NO
To examine the efficacy and safety of rTMS with new protocol in patients with treatment-resistant depression or bipolar depression
Safety,Efficacy
Change in the total QIDS-J score at 5 week
・The rates of response and remission at 5 week.
・Change in the PHQ-9, YMARS and THINC-it score at baseline compared to after TMS stimulation.
・Adverse events.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
High-frequency left prefrontal rTMS(120% of motor threshold, 10 pulses per second, 4 second on-time, 11 second off-time, 150 trains, 6,000 total pulses/session), two times weekly, for 5 weeks
High-frequency left prefrontal rTMS(120% of motor threshold, 10 pulses per second, 4 second on-time, 11 second off-time, 75 trains, 3,000 total pulses/session), four times weekly, for 5 weeks
25 | years-old | <= |
75 | years-old | >= |
Male and Female
1)MDD or bipolar disorder
2) More after 4 weeks of treatment with fixed regimen of medication and/or psychotherapy
3)Total QIDS-J >=11 at baseline
1)Unable 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) Patients who did not respond to rTMS or ECT
10)Present suicidal risk as assessed by the investigator or a history of attempted suicide in the last 3 years.
11)Any self-inflicted harm in the past
12)Implantation of metal object in upper body
13)Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
14)Implanted neurostimulators
15)Abnormal MRI
16)Women who are pregnant or breast-feeding
17)Clinically significant laboratory abnormality, in the opinion of the investigator based on CBC and biochemistry
30
1st name | |
Middle name | |
Last name | Shinsuke Kito |
Jikei University School of Medicine
Department of Psychiatry
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8461, Japan
03-3433-1111
kito@jikei.ac.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
2018 | Year | 04 | Month | 25 | Day |
Unpublished
4
Terminated
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 04 | Month | 25 | Day |
2019 | Year | 03 | Month | 31 | Day |
2018 | Year | 04 | Month | 19 | Day |
2019 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036832
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