UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011698
Receipt number R000013679
Scientific Title Study of oxytocin interaction in children with developmental disorders
Date of disclosure of the study information 2013/09/10
Last modified on 2021/04/14 14:08:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

University of Fukui, Research Center for Child Mental Development

Institute

Department

Personal name



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


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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name