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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000024339 |
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Date of registration:
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07/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:open-label study
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Scientific title:
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Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:open-label study - Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities |
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Date of first enrolment:
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2016/11/24 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028025 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Chie
Aita |
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Address:
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160 mitsu yoshinogari saga japan
Japan |
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Telephone:
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0952-52-3231 |
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Email:
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ai-chie@po.bunbun.ne.jp |
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Affiliation:
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National Hospital Organization Hizen Psychiatric Center medical office |
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Name:
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Chie
Aita |
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Address:
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160 mitsu yoshinogari saga japan
842-0192
Japan |
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Telephone:
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0952-52-3231 |
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Email:
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ai-chie@po.bunbun.ne.jp |
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Affiliation:
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National Hospital Organization Hizen Psychiatric Center medical office |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
18years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Autism spectrum disorder severe intellectual disabilities
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Intervention(s)
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8 weeks administration of intranasal oxytocin(16IU/dose)
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Primary Outcome(s)
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After 8 weeks administration of intranasal oxytocin The Japanese version of the RBS-R(Repetitive Behavior Scale-Revised)(stereotyped,self-injurious)
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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National Hospital Organization Hizen Psychiatric Center
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Ethics review
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Status: YES
Approval date: 08/07/2016
Contact:
kanri-kacyou@hizen2.hosp.go.jp
National Hospital Organization Hizen Psychiatric Center
0952-52-3231
kanri-kacyou@hizen2.hosp.go.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2018 |
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URL:
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