UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024770 |
|---|---|
| Receipt number | R000028495 |
| Scientific Title | Relationship between Visual Attention for Social Information and Salivary Oxytocin Levels in Autism Spectrum Disorders |
| Date of disclosure of the study information | 2016/11/08 |
| Last modified on | 2016/11/08 22:02:09 |
* 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
Relationship between Visual Attention for Social Information and Salivary Oxytocin Levels in Autism Spectrum Disorders
Acronym
Visual Attention for Social Information and Salivary Oxytocin Levels in ASD
Scientific Title
Relationship between Visual Attention for Social Information and Salivary Oxytocin Levels in Autism Spectrum Disorders
Scientific Title:Acronym
Visual Attention for Social Information and Salivary Oxytocin Levels in ASD
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationships between visual attention for social information and oxytocin (OT) levels in autism spectrum disorder (ASD) and typical development (TD).
Basic objectives2
Others
Basic objectives -Others
To investigate the relationships between visual attention for social information and oxytocin (OT) levels in autism spectrum disorder (ASD) and typical development (TD).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual attention for social information mesured by GazeFinder
Key secondary outcomes
OT
WAIS-3
PHQ-9
GAD-7
SDISS
EQ-5D
BDI
STAI
ADOS
PARS
AQ
SRS-2
RAADS-14
ASRS
CAARS
Vineland-II
SES
Edinburgh inventory
Neuropsychological test
NIRS
Heart rate
SCL
WISC
DSRS-C
SCAS
CBCL
SDQ
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
Visual attention for the social information.
Interventions/Control_2
Visual attention for the social information.
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
| 0 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASD group
To meet the diagnostic criteria for ASD as a primary diagnostic.
TD group
Individuals who do not meet the criteria for ASD nor other psychiatric disorders.
Key exclusion criteria
Individuals who have histories of substance abuse, active sucidality, severe mental and physical condition.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hirano |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262975
hirano@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aki Tsuchiyagaito |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262975
Homepage URL
a-tsuchiyagaito@umin.ac.jp
Sponsor or person
Institute
Research Center for Child Mental Development, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
| 2016 | Year | 11 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 17 | 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
| 2016 | Year | 11 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028495
