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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042643
Receipt No. R000048659
Scientific Title Study on brain serotonin release
Date of disclosure of the study information 2021/01/15
Last modified on 2021/06/10

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Basic information
Public title Study on brain serotonin release
Acronym Serotonin release PET
Scientific Title Study on brain serotonin release
Scientific Title:Acronym Serotonin release PET
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to estimate the release of serotonin in the brain by examining quantitatively the accumulation of 11C-AZ10419369 which binds to 5HT1B.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Elucidation of the binding capacity of the tracer by examining the level of changes before and after stimulation
Key secondary outcomes Correlation of the tracer binding with psychological and MRI data

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
Other
Interventions/Control_1 PET measurement after intravenous tracer injection
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
85 years-old >=
Gender Male
Key inclusion criteria 1.Healthy participants aged 20 to 84 years
2.Individuals who have no history of psychiatric disease
3.Individuals who are right-handed
4.Individuals who are consent to participate in this study
5.Critetria for elderly subject: 1) Individuals with Mini-mental state examination scores over 26 at screening, 2) Individuals with Clinical dementia rating scale score 0, 3)Individuals whose ADL is normal without any memory problems
Key exclusion criteria 1.Individuals who have a history of traumatic brain injury with an unconsciousness lasting more than 5 minutes
2.Individuals who have a history of organic brain disease
3.Individuals who have a history of substance dependence
4.Individuals who are taking central nervous system stimulants
5.Individuals who have a history of disorders of consciousness and/or seizure
6.Individuals who have a chronic headache
7.Individuals who have a risk for MRI scan
8. Individuals who are considered unsuitable by doctors in charge
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Yasuomi
Middle name
Last name Ouchi
Organization Hamamatsu University School of Medicine
Division name Department of Biofunctional Imaging
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL 053-435-2466
Email ouchi@hama-med.ac.jp

Public contact
Name of contact person
1st name Yasuomi
Middle name
Last name Ouchi
Organization Hamamatsu University School of Medicine
Division name Department of Biofunctional Imaging
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL 053-435-2466
Homepage URL
Email ouchi@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Hamamatsu Medical Photonics Foundation
Hamamatsu Photonics KK
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel 053-435-2680
Email rinri@hama-med.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 15 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 08 Month 10 Day
Date of IRB
2020 Year 08 Month 18 Day
Anticipated trial start date
2021 Year 01 Month 15 Day
Last follow-up date
2025 Year 03 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 03 Day
Last modified on
2021 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048659

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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