UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027105 |
|---|---|
| Receipt number | R000030862 |
| Scientific Title | Multimodal observation study on electroconvulsive therapy. |
| Date of disclosure of the study information | 2017/04/24 |
| Last modified on | 2017/04/24 07:57:02 |
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Basic information
Public title
Multimodal observation study on electroconvulsive therapy.
Acronym
Multimodal observation study on electroconvulsive therapy.
Scientific Title
Multimodal observation study on electroconvulsive therapy.
Scientific Title:Acronym
Multimodal observation study on electroconvulsive therapy.
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the mechanism of electroconvulsive therapy
Basic objectives2
Others
Basic objectives -Others
Elucidation of the mechanism of electroconvulsive therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sequential change of representative index obtained by each examination (MRI, NIRS, EEG), series of ECT treatment.
Key secondary outcomes
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
1)Who met the criteria for a depressive episode (either unipolar or bipolar disorder)
2) Who were scheduled to undergo electroconvulsive therapy at Keio University Hospital in Japan.
3) Who were judged by the attending physician that Informed consent can be acquired
Key exclusion criteria
1)Stupor
2)With internal metals or pacemakers
3)Unstable medical condition
4)History of significant head trauma.
5)Pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3829
hiroyuki.uchida.hu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jinichi Hirano |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3829
Homepage URL
hjinichi@keio.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 04 | Month | 24 | 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
| 2017 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Three times NIRS scanning, MRI imaging, Electroencepharograh are performed. Scan timing is before the course of ECT treatment, after three sessions of ECT and after the series of ECT treatment.
Management information
Registered date
| 2017 | Year | 04 | Month | 24 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030862
| 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 |
