UMIN-CTR Clinical Trial

Basic information
Public title	Neural mechanism of voice processing in autism spectrum disorder and schizophrenia
Acronym	Voice processing in ASD and schizophrenia
Scientific Title	Neural mechanism of voice processing in autism spectrum disorder and schizophrenia
Scientific Title:Acronym	Voice processing in ASD and schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	To clarify neural network in processing of human voice in ASD and Schizophrenia by using fMRI
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	fMRI, 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	3
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Individuals with autism spectrum disorder
Interventions/Control_2	individuals with schizophrenia
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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	Individuals with autism spectrum disorder: 1) Individuals who is diagnosed as autism spectrum disorder based on DSM-V 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 Individuals with schizophrenia: 1) Individuals who is diagnosed as schizophrenia based on DSM-V 2) Individuals who do not have any other neurological or psychiatric disorders 3) Individuals 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	Individuals with autism spectrum disorder (ASD) and normal controls 1) with implanted cardiac pacemaker 2) with surgical aneurysm clips 3) with neurostimulator 4) with implanted pumps 5) with metal fragments in body 6) with tattoos, permanent eyeliner (if ink contains metallic specks) 7) with pregnancy and at risk of becoming pregnant 8) Subjects who are judged as unsuitable for participation in this study by their primary doctor (individuals with ASD only)
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobumasa Kato
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo
TEL	03-3300-5231
Email	katon@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Rieko Okada
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo
TEL	03-3300-5231
Homepage URL
Email	rokada@med.showa-u.ac.jp

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

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	2016 Year 10 Month 04 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	2016 Year 07 Month 01 Day
Date of IRB	2016 Year 01 Month 26 Day
Anticipated trial start date	2016 Year 09 Month 30 Day
Last follow-up date	2018 Year 09 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 04 Day
Last modified on	2019 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026696