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 |
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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
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
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
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
