UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042775 |
|---|---|
| Receipt number | R000048098 |
| Scientific Title | Establishment and management of postmortem brain bank for psychiatric research |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2020/12/17 12:31:50 |
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Basic information
Public title
Establishment and management of postmortem brain bank for psychiatric research
Acronym
Establishment and management of postmortem brain bank for psychiatric research
Scientific Title
Establishment and management of postmortem brain bank for psychiatric research
Scientific Title:Acronym
Establishment and management of postmortem brain bank for psychiatric research
Region
| Japan |
Condition
Condition
Schizophrenia, mood disorders, anxiety disorders and developmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Optimization of postmortem brain sample collection
Basic objectives2
Others
Basic objectives -Others
Distribution of brain samples
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Postmortem brain sample collection
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) Psychiatric disorders (schizophrenia, mood disorders, anxiety disorders, developmental disorders, etc.) and controls (no history of central nervous system diseases including mental disorders) accurately diagnosed by DSM-5
(2) Of the above, cases where the antemortem consent of the subject and the consent of the bereaved family were obtained, or cases where the consent of the bereaved family was obtained.
Key exclusion criteria
At the time of death, If the registrant is any of the following;
(1) When the head of the body is significantly damaged due to a traffic accident, etc.
(2) Brain death, when wearing a respirator for a long time
(3) If she/he has an infectious disease (hepatitis B, hepatitis C, tuberculosis, HIV, syphilis, prion disease such as Creutzfeldt-Jakob disease, new coronavirus, etc.)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tomita |
Organization
Tohoku University
Division name
Department of Psychiatry, Graduate School of Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177262
htomita@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuto |
| Middle name | |
| Last name | Kunii |
Organization
Tohoku University
Division name
Department of Disaster Psychiatry, International Research Institute of Disaster Science
Zip code
980-8573
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177897
Homepage URL
kunii@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-3867
med-kenkyo@grp.tohoku.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
| 2021 | Year | 01 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | 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 | 12 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048098
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
