UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042643 |
|---|---|
| Receipt number | R000048659 |
| Scientific Title | Study on brain serotonin release |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/06/10 15:47:25 |
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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
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
ouchi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048659
