UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040596 |
|---|---|
| Receipt number | R000045791 |
| Scientific Title | The mapping analysis using multi-channel electroencephalograph in electroconvulsive therapy |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2022/12/25 09:26:52 |
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Basic information
Public title
The mapping analysis using multi-channel electroencephalograph in electroconvulsive therapy
Acronym
The mapping analysis using multi-channel electroencephalograph in electroconvulsive therapy
Scientific Title
The mapping analysis using multi-channel electroencephalograph in electroconvulsive therapy
Scientific Title:Acronym
The mapping analysis using multi-channel electroencephalograph in electroconvulsive therapy
Region
| Japan |
Condition
Condition
depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the electrophysiological mechanism by analysing multi-channel electroencephalogram during electroconvulsive therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the multi-channel electroencephalogram
Key secondary outcomes
depression rating scale
rating scale of cognitive function
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
inpatients diagnosed major depressive episode
Key exclusion criteria
patients who can not be received electroconvulsive therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Yasuda |
Organization
the University of Yamanashi
Division name
faculty of medicine, department of neuropsychiatry
Zip code
4093898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
0552739847
kyasuda@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Yasuda |
Organization
the University of Yamanashi
Division name
faculty of medicine, department of neuropsychiatry
Zip code
4093898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
0552739847
Homepage URL
kyasuda@yamanashi.ac.jp
Sponsor or person
Institute
the University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
the University of Yamanashi
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi IRB
Address
1110, Shimokato, Chuo, Yamanashi
Tel
0552731111
miwakoa@yamanashi.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 30 | 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
| 2020 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2020 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045791
| 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 |
