UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044836 |
|---|---|
| Receipt number | R000051194 |
| Scientific Title | The effects of repetitive transcranial magnetic stimulation (rTMS) for cognitive function of depression: prospective observational study |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2023/10/10 18:42:39 |
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Basic information
Public title
The effects of repetitive transcranial magnetic stimulation (rTMS) for cognitive function of depression: prospective observational study
Acronym
The effects of rTMS for depression: prospective observational study
Scientific Title
The effects of repetitive transcranial magnetic stimulation (rTMS) for cognitive function of depression: prospective observational study
Scientific Title:Acronym
The effects of rTMS for depression: prospective observational study
Region
| Japan |
Condition
Condition
depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of rTMS for depression on depressive symptoms and cognitive function in real world clinical settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Patient Health Questionnaire -9(PHQ-9)
Key secondary outcomes
Japanese version of THINC integrated-tool
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who underwent rTMS during the study period and are able to make their consent for study participation
Key exclusion criteria
Patients who are judged by the principal investigator to be unsuitable for participation in the study
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kito |
Organization
The Jikei university school of medicine
Division name
Department of Psychiatry
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0334331111
kito@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Yamazaki |
Organization
The Jikei university school of medicine
Division name
Department of Psychiatry
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
yamazaki.1173@gmail.com
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei university school of medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
Tel
0334331111
rinri@jikei.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
東京慈恵会医科大学附属病院（東京都）
国立精神・神経医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051194
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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