UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032313 |
|---|---|
| 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 |
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Basic information
Public 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
Acronym
Efficacy and safety of rTMS with new protcol in treatment-resistant MDD and BD
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
Scientific Title:Acronym
Efficacy and safety of rTMS with new protcol in treatment-resistant MDD and BD
Region
| Japan |
Condition
Condition
Major depressive disorder and bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of rTMS with new protocol in patients with treatment-resistant depression or bipolar depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the total QIDS-J score at 5 week
Key secondary outcomes
･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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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
Interventions/Control_2
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
kito@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihide Hayashi |
Organization
Medical Care Toranomon
Division name
Medical Care Toranomon
Zip code
Address
1-16-16 Toranomon, Minatoku, Tokyo 105-0001, Japan
TEL
03-5510-3898
Homepage URL
dtms@medcare-tora.com
Sponsor or person
Institute
Medical Care Toranomon
Institute
Department
Personal name
Funding Source
Organization
Medical Care Toranomon
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
4
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036832
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