UMIN-CTR Clinical Trial

Basic information
Public title	Searching neural correlates of changes in social impairments induced by intranasal oxytocin administration and its association with genotypes related to oxytocin in subjects with autism spectrum disorder
Acronym	Searching changes in brain activation induced by intranasal oxytocin and its association with genotypes related to oxytocin in subjects with autism spectrum disorder
Scientific Title	Searching neural correlates of changes in social impairments induced by intranasal oxytocin administration and its association with genotypes related to oxytocin in subjects with autism spectrum disorder
Scientific Title:Acronym	Searching changes in brain activation induced by intranasal oxytocin and its association with genotypes related to oxytocin in subjects with autism spectrum disorder
Region	Japan

Condition
Condition	Autism spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	1) Examining functional Magnetic Resonance Imaging signal changes induced by intranasal oxytocin administration in subjects with autism spectrum disorder 2) Examining association between functional Magnetic Resonance Imaging signal changes induced by intranasal oxytocin and genotypes related to oxytocin in subjects with autism spectrum disorder
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bold signal changes of functional Magnetic Resonance Imaging
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single intranasal administration of 24 units oxytocin (Syntocinon spray)
Interventions/Control_2	Single intranasal administration of placebo
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	55 years-old >
Gender	Male
Key inclusion criteria	1) Subjects diagnosed with high-functioning autism, Asperger disorder, or pervasive developmental disorder not otherwise specified using Autism Diagnostic Interview-Revised 2) Subjects with normal intelligent (Verbal IQ > 90 and total IQ > 80 measured with Wechsler Adult Intelligent Scale Revised)
Key exclusion criteria	1) History of allergy for oxytocin 2) Cannot enter Magnetic Resonance Scanner 3) History of traumatic brain injury with any known cognitive consequences or loss of consciousness for more than 5 minutes 4) History of substance abuse or addiction 5) Instabilized with psychiatric comorbidity
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidenori Yamasue
Organization	Graduate School of Medicine, University of Tokyo
Division name	Department of Neuropsychiatry
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The University of Tokyo Hospital
Division name	Clinical Research Center
Zip code
Address
TEL	3-5800-8743
Homepage URL
Email

Sponsor
Institute	Department of Neuropsychiatry, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Other
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	2010 Year 10 Month 15 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	2010 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 15 Day
Last modified on	2011 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005250

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.