UMIN-CTR Clinical Trial

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
Email	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
Email	omorege.naoko@qst.go.jp

Sponsor
Institute	National Institutes for Quantum Science and Technology Quantum Life and Medical Science Directorate Institute for Quantum Medical Science
Institute
Department

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
Email	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 01 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040081