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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013798
Receipt No. R000016102
Scientific Title PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Date of disclosure of the study information 2014/06/01
Last modified on 2016/08/09

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Basic information
Public title PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Acronym PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Scientific Title PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Scientific Title:Acronym PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The binding potential ratio of the serotonin 2A receptor Binding potential and D2 receptor Binding potential in the each subregions of the prefrontal cortex
Key secondary outcomes

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 PET/MRI/neuropsychological batteries/neurological examinations
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
40 years-old >
Gender Male
Key inclusion criteria 20y.o.<=40<y.o.healthy male volunteers participated in the study Serotonergic system and subjective perception
Healthy volunteers eligible for this study
Healthy volunteers with ability to make informed consent
Key exclusion criteria History of psychiatric diseases, sever physical diseases, neurological diseases
Implanted metal or tatto in the body
Claustrophobia
Those who was considered to be inapptopriate to participate in the study
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Kimura
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 81432063025
Email y-kimura@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ishii
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 81432063025
Homepage URL
Email tishii@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
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
Address
Tel
Email

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
2014 Year 06 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 Completed
Date of protocol fixation
2014 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 23 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016102

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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