UMIN-CTR Clinical Trial

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
Email	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
Email	katounagi.y@gmail.com

Sponsor
Institute	Hamamatsu University school of medicine
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033364