UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042765 |
|---|---|
| Receipt number | R000048753 |
| Scientific Title | In vivo imaging of distribution of serotonin 1B receptor and synaptic density in autism spectrum disorder: a case-control comparison with positron emission tomography. |
| Date of disclosure of the study information | 2020/12/17 |
| Last modified on | 2021/04/13 23:11:00 |
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Basic information
Public title
In vivo imaging of serotonin 1B receptor and synaptic density in autism spectrum disorder: a positron emission tomography study.
Acronym
In vivo imaging of serotonin 1B receptor and synaptic density in ASD using PET.
Scientific Title
In vivo imaging of distribution of serotonin 1B receptor and synaptic density in autism spectrum disorder: a case-control comparison with positron emission tomography.
Scientific Title:Acronym
In vivo imaging of serotonin 1B receptor and synaptic density in ASD using PET.
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the difference in distributions of serotonin 1B receptor and synaptic vesicle glycoprotein 2A, a synaptic density marker, between autism spectrum disorder and typically developing subjects using positron emission tomography.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationships between behavioral and functional/structural neural measures and distributions of serotonin 1B receptor and synaptic vesicle glycoprotein 2A by utilizing psychological measurements and MRI scans.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Distributions of serotonin 1B receptor and synaptic vesicle glycoprotein 2A measured with PET.
Key secondary outcomes
Behavioral and functional/structural neural measures quantified with psychological assessments and MRI scans.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
Male subjects diagnosed with ASD or typically developing male subjects.
Key exclusion criteria
1) Current or past medical histories of brain organic diseases.
2) Comorbidity of substance-related disorders.
3) Contraindications on MRI scanning.
4) For the case of typically developing subjects, current or past medical histories of psychiatric disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Yamasue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan.
TEL
053-435-2295
yamasue@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Yokokura |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan.
TEL
053-435-2295
Homepage URL
ykkr@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Photonics Medical Foundation, Hamamatsu Photonics K.K.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 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
| 2020 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Case-control study.
2) We will recruit study participants in the institutions from January, 2021 to October, 2025.
3) The participants undergo PET, MRI, and psychological measurements.
Management information
Registered date
| 2020 | Year | 12 | Month | 16 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048753
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
