UMIN-CTR Clinical Trial

Basic information
Public title	Study about social decision making of individuals with autism spectrum disorder
Acronym	Study about social decision making of individuals with autism spectrum disorder
Scientific Title	Study about social decision making of individuals with autism spectrum disorder
Scientific Title:Acronym	Study about social decision making of individuals with autism spectrum disorder
Region	Japan

Condition
Condition	Autism spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the deficit of social decision making in individuals with autism spectrum disorder quantitatively, using experimental economic game.
Basic objectives2	Others
Basic objectives -Others	The relationship between the symptom of autism spectrum disorder and the way of social decision making.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Psychological tests and neuroimaging data
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Individuals with autism spectrum disorder
Interventions/Control_2	Healthy controls
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Patients 1) Individuals diagnosed as autism spectrum disorder based on DSM-IV-TR 2) Individuals who do not have any other severe neuropsychiatric disorders and physical illness. 3) Individuals whose IQs are more than 80, and who can give written informed consent Normal controls 1) Individuals who do not have no neurological or psychiatric disorders 2) Individuals whose estimated IQs are more than 80, and who can give written informed consent
Key exclusion criteria	a person with neurological disorders or disease which could affect central nervous system, and a person who does not have competence to consent
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidehiko TAKAHASHI
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code
Address	54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3386
Email	hidehiko@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masanori ISOBE
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code
Address	54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-4947
Homepage URL
Email	masaniso@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Medical Institute of Developmental Disabilities Research, Showa university
Institute
Department

Funding Source
Organization	Medical Institute of Developmental Disabilities Research, Showa university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 03 Month 01 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	Completed
Date of protocol fixation	2014 Year 10 Month 31 Day
Date of IRB	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 02 Month 10 Day
Last modified on	2020 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019139