UMIN-CTR Clinical Trial

Basic information
Public title	Study of oxytocin interaction in children with developmental disorders
Acronym	Oxytocin development research
Scientific Title	Study of oxytocin interaction in children with developmental disorders
Scientific Title:Acronym	Oxytocin development research
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Pediatrics Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Relation of serum oxytocin concentration, oxytocin receptor gene polymorphism, autism spectrum disorder symptoms, and hippocampus volume
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Social Responsiveness Scale Serum oxytocin concentration
Key secondary outcomes	oxytocin receptor gene polymorphism Whole brain volume

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	8 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Have a clinical diagnosis of Autism spectrum disorder confirmed according to DSM-IV criteria, or subjects who have no current diagnosis. 2) Subjects within the age range of 8-17 years old. 3) Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Key exclusion criteria	1) Subjects who have not yet received informed consent of the current diagnosis. 2) Global intelligence impairment that may interfere with conduct of the study(WISC<70). 3) Subjects who, in the investigator's opinion, might not be suitable for the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akemi Tomoda
Organization	University of Fukui, Child Mental Research Center
Division name	Age2 Division
Zip code
Address	Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN 910-1193
TEL	0776-61-8677
Email	atomoda@u-fukui.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Chiho Yatsuga
Organization	University of Fukui, Research Center for Child Mental Development
Division name	Age2 Division
Zip code
Address	Matsuoka Shimoaizuki 23-3, Eiheiji, Fukui, JAPAN, 910-1193
TEL	0776-61-8677
Homepage URL
Email	cyatsuga@u-fukui.ac.jp

Sponsor
Institute	University of Fukui, Research Center for Child Mental Development
Institute
Department

Funding Source
Organization	Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
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	2013 Year 09 Month 10 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 06 Day
Date of IRB	2012 Year 07 Month 20 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2014 Year 03 Month 30 Day

Other
Other related information	.Oxyctocin concentration and ASD symptoms .Brain colume and ASD symptoms .Oxytocin concentration and brain volume

Management information
Registered date	2013 Year 09 Month 10 Day
Last modified on	2021 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013679