UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035206 |
|---|---|
| Receipt number | R000040081 |
| Scientific Title | Neural basis of cognitive responses toward social stressors |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2022/03/24 11:40:21 |
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Basic information
Public title
Neural basis of cognitive responses toward social stressors
Acronym
Neural basis of cognitive responses toward social stressors
Scientific Title
Neural basis of cognitive responses toward social stressors
Scientific Title:Acronym
Neural basis of cognitive responses toward social stressors
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the neural basis of the cognitive responses following a mild social stressor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationships between rumination, BOLD signal, and other physiological responses.
Key secondary outcomes
The relationships between cognitive functions, psychological traits, and other physiological responses.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Psychological test: 95min
Break time
2. MRI scan: 30min (including preparation and explanation)
3. Social stress test: 30min
3. MRI scan: 30min (including preparation and explanation)
4. Debriefing and recovery: 10min
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals who have the ability to provide informed consent.
2. Individuals who have normal and corrected eyesight.
Key exclusion criteria
Psychiatric disorders including drug dependence
Serious medical illness
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes for Quantum Science and Technology
Quantum Life and Medical Science Directorate
Institute for Quantum Medical Science
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3251
yamada.makiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Omorege |
Organization
National Institutes for Quantum Science and Technology Institute for Quantum Medical Science
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3025
Homepage URL
omorege.naoko@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Quantum Life and Medical Science Directorate
Institute for Quantum Medical Science
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Quantum Life and Medical Science Directorate
Institute for Quantum Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel
043-206-4709
helsinki@qst.go.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
| 2019 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040081
