UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027827 |
|---|---|
| Receipt number | R000031884 |
| Scientific Title | Multi-Modal study for the Maintenance of Remission after Electroconvulsive therapy (ECT) |
| Date of disclosure of the study information | 2017/06/20 |
| Last modified on | 2017/06/20 08:19:27 |
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Basic information
Public title
Multi-Modal study for the Maintenance of Remission after Electroconvulsive therapy (ECT)
Acronym
Multi-Modal study for the Maintenance of Remission after Electroconvulsive therapy (ECT)
Scientific Title
Multi-Modal study for the Maintenance of Remission after Electroconvulsive therapy (ECT)
Scientific Title:Acronym
Multi-Modal study for the Maintenance of Remission after Electroconvulsive therapy (ECT)
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the biological mechanisms of the keeping the remission after ECT
Basic objectives2
Others
Basic objectives -Others
To clarify the biological mechanisms of the keeping the remission after ECT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the NIRS scan, electroencephalogram scan, MRI scan at discharge, between remission maintenance group (12 months after discharge) and relapsing group.
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, 20 years and over
2, Meet the criteria of major depression or bipolar depression by Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
3, Remission state that is treated by the electroconvulsive therapy
Key exclusion criteria
1, With internal metals or pacemakers
2, With serious physical disorders
3, History of head injury with severe neurological sequelae
4, 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, Japan
TEL
03-5363-3971
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, Japan
TEL
03-5363-3971
Homepage URL
hjinichi@gmail.com
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Advanced Telecommunications Research Institute International
Organization
Division
Category of Funding Organization
Profit organization
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 | 06 | Month | 20 | 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 | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
MRI scan, EEG scan, NIRS scan, symptom assessment are performed at discharge from the hospital. In addition, symptom assessment and questionnaire survey will be conducted by postal mail, 6 and 12 months after discharge.
For the cases agreeing to visit our site at 6 and 12 months after discharge, MRI scan, EEG scan, NIRS scan, symptom assessment are performed.
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031884
| Research Plan | |
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| 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 |
