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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024339
Receipt No. R000028025
Scientific Title Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:open-label study
Date of disclosure of the study information 2016/10/07
Last modified on 2019/04/01

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Basic information
Public title Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:open-label study
Acronym Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities
Scientific Title Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:open-label study
Scientific Title:Acronym Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities
Region
Japan

Condition
Condition Autism spectrum disorder
severe intellectual disabilities
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the efficacy and safety of oxytocin nasal administration to the Autism spectrum disorders with severe intellectual disabilities
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes After 8 weeks administration of intranasal oxytocin
The Japanese version of the RBS-R(Repetitive Behavior Scale-Revised)(stereotyped,self-injurious)
Key secondary outcomes The Japanese version of the RBS-R(Repetitive Behavior Scale-Revised)(compulsive,ritualistic,sameness,restricted interests)
The Japanese version of the Aberrant Behavior Checklist(Illitability)
The Japanese version of the Sensory Profile Short Version
CGI-S
CGI-I
plasma oxytocin ,salivary oxytocin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 8 weeks administration of intranasal oxytocin(16IU/dose)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Autism Spectrum Disorders with behavioral problem
ABC-J irritability subscale 18 points or more
CGI-S 4 points(Moderatory ill) or more
moderatory,severe,profound intellectual disabilities
self-standing position possible
inpatient
Key exclusion criteria CARS-TV less than 30 points
self-standing position impossible
Weighing less than 20kg
History of status epilepticus
Possibility of pregnancy
Body exhaustion and advanced inspection value or more
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Chie
Middle name
Last name Aita
Organization National Hospital Organization Hizen Psychiatric Center
Division name medical office
Zip code 842-0192
Address 160 mitsu yoshinogari saga japan
TEL 0952-52-3231
Email ai-chie@po.bunbun.ne.jp

Public contact
Name of contact person
1st name Chie
Middle name
Last name Aita
Organization National Hospital Organization Hizen Psychiatric Center
Division name medical office
Zip code 842-0192
Address 160 mitsu yoshinogari saga japan
TEL 0952-52-3231
Homepage URL http://www.hizen-hosp.jp/pdf/rinri/gijiroku/2016/2016.04.28.pdf
Email ai-chie@po.bunbun.ne.jp

Sponsor
Institute National Hospital Organization Hizen Psychiatric Center
Institute
Department

Funding Source
Organization National Hospital Organization Hizen Psychiatric Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Psychiatry,Faculty of Medicine University of Saga
Research Center for Child Mental Development University of Fukui
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Hizen Psychiatric Center
Address 160 mitsu yoshinogari saga japan
Tel 0952-52-3231
Email kanri-kacyou@hizen2.hosp.go.jp

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 国立病院機構 肥前精神医療センター(佐賀県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 07 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 7
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason About construction schedule again about oxytocin concentration measurement(Add extraction).
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
2016 Year 06 Month 20 Day
Date of IRB
2016 Year 07 Month 08 Day
Anticipated trial start date
2016 Year 11 Month 24 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 07 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028025

Research Plan
Registered date File name
2017/04/09 (臨床研究センター修正版)佐賀大学実施計画書最終版2016.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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