UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014257 |
|---|---|
| Receipt number | R000016607 |
| Scientific Title | Neuroimaging and physiological studies in psychiatric disorders with cognitive and emotional dysfunction |
| Date of disclosure of the study information | 2014/06/14 |
| Last modified on | 2020/06/23 13:55:58 |
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Basic information
Public title
Neuroimaging and physiological studies in psychiatric disorders with cognitive and emotional dysfunction
Acronym
Neuroimaging and physiological studies in psychiatric disorders
Scientific Title
Neuroimaging and physiological studies in psychiatric disorders with cognitive and emotional dysfunction
Scientific Title:Acronym
Neuroimaging and physiological studies in psychiatric disorders
Region
| Japan |
Condition
Condition
psychiatric disorders with cognitive and emotional dysfunction
Classification by specialty
| Psychiatry | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify pathology of neuropsychiatric disorders
Basic objectives2
Others
Basic objectives -Others
to clarify pathology of neuropsychiatric disorders
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluating structural and functional brain changes and associations between brain changes and physiological function
Key secondary outcomes
evaluating changes of physiological function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Comparing structural and functional brain changes between patients with psychiatric disorders and healthy control subjects using MR images. Evaluating associations between brain changes and physiological changes.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
psychiatric disorders diagnosed by diagnostic criteria
Key exclusion criteria
having past history of trauma, seizures with loss of the conscious, or abuse of drugs
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Asami |
Organization
Yokohama City University
Division name
Psychiatry
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2667
t_asami@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Asami |
Organization
Yokohama City University
Division name
Psychiatry
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2667
Homepage URL
t_asami@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-aid for scientific research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Yokohama City University Ethical Review Board
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-370-7627
ynextedu@yokohama-cu.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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 14 | 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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 13 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016607
| 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 |
