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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002241
Receipt No. R000002743
Scientific Title Pilot study searching neural correlates of changes in social impairments induced by intranasal oxytocin administration in subjects with autism spectrum disorder
Date of disclosure of the study information 2009/08/01
Last modified on 2010/07/26

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Basic information
Public title Pilot study searching neural correlates of changes in social impairments induced by intranasal oxytocin administration in subjects with autism spectrum disorder
Acronym Pilot study searching changes in brain activation induced by intranasal oxytocin administration in subjects with autism spectrum disorder
Scientific Title Pilot study searching neural correlates of changes in social impairments induced by intranasal oxytocin administration in subjects with autism spectrum disorder
Scientific Title:Acronym Pilot study searching changes in brain activation induced by intranasal oxytocin administration in subjects 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 1) Examining neural correlates of changes in social impairments, as revealed by functional Magnetic Resonance Imaging signal changes, induced by intranasal oxytocin administration in subjects with autism spectrum disorder
2) Examining the safety of intranasal oxytocin administration in subjects with autism spectrum disorder
3) Examining the efficacy of intranasal oxytocin administration for social impairments in subjects with autism spectrum disorder
Basic objectives2 Safety,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 03-5800-9263
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
Homepage URL http://www.crc.h.u-tokyo.ac.jp/index.html
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
2009 Year 08 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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 23 Day
Last modified on
2010 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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