UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	Autism is a neurobiological condition with a strong genetic component characterized by impairments in social interaction and communication as well as restricted, repetitive, and stereotyped patterns of behavior, interests, and activities. Family studies have indicated that concordance rates for autism are 2% to 6% for siblings and dizygotic twins and approximately 60% for monozygotic twins. Still, most siblings of probands with autism do not have any symptoms of autism despite sharing, on average, 50% of their genes and many environmental influences with their siblings with autism. Furthermore, previous studies have suggested that individuals with autism share some aspects of brain structure and function as well as behavioral and immune profiles with their siblings who do not have autism. Therefore, we sought to investigate the similarity and difference of brain anatomy and function among individuals with high-functioning autism spectrum disorder and their siblings to reveal the neurobiological and genetic substrates in high-functioning autism spectrum disorder.
Basic objectives2	Others
Basic objectives -Others	To detect the neurobiological substrates in autism spectrum disorder.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Voxel-based Morphometry (VBM) 2. Diffusion Tensor Imaging (DTI) 3. Free Surfer 4. Functional MRI (fMRI)
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	3
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Individuals with autism spectrum disorder
Interventions/Control_2	Siblings of autism spectrum disorder
Interventions/Control_3	Normal controls
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	Not applicable
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Participants diagnosed as an autism spectrum disorder recruited from Showa university karasuyama hospital, their same-sex unaffected siblings, and healthy controls
Key exclusion criteria	Participants have any other neurological or psychiatric disorders
Target sample size	90

Research contact person
Name of lead principal investigator	Osamu Takashio
Organization	Showa University School of Medicine
Division name	Department of Psychiatry
Address	6-11-11 Kita-Karasuyama, Setagaya-Ku, Tokyo, Japan
TEL	03-3300-5231
Email	takashio@med.showa-u.ac.jp

Public contact
Name of contact person	Bun Yamagata
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3829
Homepage URL
Email	yamagata@a6.keio.jp

Sponsor
Institute	Showa University School of Medicine, Department of Psychiatry
Institute
Department

Funding Source
Organization	Grant-in-Aid forYoung Scientists (B)
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	昭和大学附属烏山病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 02 Month 24 Day
Anticipated trial start date	2014 Year 05 Month 01 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 03 Month 17 Day
Last modified on	2016 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015633