UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029183 |
|---|---|
| Receipt number | R000033364 |
| Scientific Title | Potential roles of neurotransmitter receptors and mitochondria in the pathophysiology of autism spectrum disorder: A PET study |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2022/09/24 21:22:23 |
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Basic information
Public title
Potential roles of neurotransmitter receptors and mitochondria in the pathophysiology of autism spectrum disorder: A PET study
Acronym
Neurotransmitter receptors and mitochondria
in autism spectrum disorder
Scientific Title
Potential roles of neurotransmitter receptors and mitochondria in the pathophysiology of autism spectrum disorder: A PET study
Scientific Title:Acronym
Neurotransmitter receptors and mitochondria
in autism spectrum disorder
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Autism spectrum disorder (ASD) is a highly prevalent neurodevelopmental disorder as high as 1%. No pharmacological treatment for its core symptoms has been established. Although mitochondria and neurotransmitters such as dopamine might play a role in the pathophysiology of ASD, previous studies have not fully elucidated it. Furthermore, a potential role of their interactions has not yet been tested.The current study will test the role of dopamine and mitochondria and their interactions in the pathophysiology of ASD by utilizing [11C]FLB457 and [18F]BCPP-EF PET.
Basic objectives2
Others
Basic objectives -Others
We will compare the binding potentials of [11C] FLB457 and standard uptake value ratio of [18F] BCPP-EF in ASD individuals with those in typically developped subjects.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The binding potentials of [11C] FLB and standard uptake value ratio of [18F] BCPP-EF
Key secondary outcomes
Indices assessed with MRI Psychological tests : ADOS-2(Autism Diagnostic Observation Schedule Second Edition),ADI-R(Autism Diagnostic Interview-Revised),AQ(Autism-Spectrum Quotient),STAI(State-Trait Anxiety Inventory),SASS( Social Adaptation Self-evaluation Scale),CES-D(The Center for Epidemiologic Studies Depression Scale),CGI-S( Clinical Global Impressions-Severity of Illness scale),WAIS-3(Wechsler Adult Intelligence Scale third edition)
Labo date:lactate,pyruvate,ammoniaasparate aminotransferase,alanine aminotransferase,creatine kinase,
creatinine
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
| Device,equipment |
Interventions/Control_1
We use[11C]-FLB457 and [18F]BCPP-EF as radiotracer by administration intravenously
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
Health control
-Without past or current history psychiatric illness
Illnesses groups
-Diagnosed as autism spectrum disorder on DSM-5
-Full IQ above 70
-Without nervous disease
Key exclusion criteria
-With current history of brain organic diseases
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
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 | Kato |
| Middle name | |
| Last name | Yasuhiko |
Organization
Hamamatsu University school of medicine
Division name
psychiatry
Zip code
4380085
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
09061277594
Homepage URL
katounagi.y@gmail.com
Sponsor or person
Institute
Hamamatsu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu Photonics
Hamamatsu Medical Photonics Foundation
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
053-435-2295
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
| 2017 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
47
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
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033364
