UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Behavioral study of gaze perception in autism spectrum disorder
Title of the study (Brief title)	Behavioral study of gaze perception in ASD
Region	Japan

Condition
Condition	Individuals with autism spectrum disorder
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the gaze perception of individuals with autism spectrum disorder at the behavioral level.
Basic objectives2	Others
Basic objectives -Others	the correlation between the gaze perception and the severity of autism spectrum disorder
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Psychological tests
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	Other
Interventions/Control_1	Individuals with autism spectrum disorder
Interventions/Control_2	Normal 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 who is diagnosed as autism spectrum disorder based on DSM-IV-TR 2) Individuals who do not have any other neurological or psychiatric disorders 3) Individuals whose IQs are more than 80, and who have capability of 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 have capability of informed consent
Key exclusion criteria	1) Subjects who are judged as unsuitable for participation in this study by their primary doctor (patients only)
Target sample size	40

Research contact person
Name of lead principal investigator	Nobumasa Kato
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Address	Kitakarasuyama 6-11-11 setagaya-ku, Tokyo
TEL	03-5315-9357
Email	katon@med.showa-u.ac.jp

Public contact
Name of contact person	Takashi Itahashi
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Address	Kitakarasuyama 6-11-11 setagaya-ku, Tokyo
TEL	03-5315-9357
Homepage URL	http://www10.showa-u.ac.jp/~BIRC/
Email	ita3@med.showa-u.ac.jp

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

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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	2014 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 10 Day
Anticipated trial start date	2014 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 11 Day
Last modified on	2018 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018077