UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026642 |
|---|---|
| Receipt number | R000030597 |
| Scientific Title | The Analysis for the Effect of Repetitive Transcranial Magnetic Stimulation in Depression |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2022/09/29 08:43:17 |
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Basic information
Public title
The Analysis for the Effect of Repetitive Transcranial Magnetic Stimulation in Depression
Acronym
rTMS
Scientific Title
The Analysis for the Effect of Repetitive Transcranial Magnetic Stimulation in Depression
Scientific Title:Acronym
rTMS
Region
| Japan |
Condition
Condition
Mental disorder with depressive state
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effects of rTMS on the brain activity in patients with depressive state were investigated
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of depression
Key secondary outcomes
Near-Infrared Spectroscopy(NIRS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
repetitive Transcranial Magnetic Stimulation (rTMS)
4000pulses/day * 12days
Interventions/Control_2
sham stimulation
4000pulses/day * 12days
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of mental disorder with depressive state
They were classified fulfilling the criteria of International Statistical Classification of Diseases and Related Health Problems-10 (ICD-10)
Key exclusion criteria
History of seizures
History of cerebral organic disease
History of indwelling metal in the body
History of drug abuse
Pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kawasaki |
Organization
Kanazawa Medical University
Division name
Department of Neuro-Psychiatry
Zip code
920-0293
Address
1-1, Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, 920-0293, Japan
TEL
076-286-2211
psychiat@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Okubo |
Organization
Kanazawa Medical University
Division name
Department of Neuro-Psychiatry
Zip code
920-0293
Address
1-1, Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, 920-0293, Japan
TEL
076-286-2211
Homepage URL
psychiat@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Department of Neuro-Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
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
Kanazawa Medical University Hospital Clinical Reseach and Trials Center
Address
1-1, Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, 920-0293, Japan
Tel
076-218-8347
tiken@kanazawa-med.ac.jp
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
金沢医科大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 22 | 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
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
| 2017 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030597
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
