UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028650 |
|---|---|
| Receipt number | R000032790 |
| Scientific Title | Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/08/14 09:28:56 |
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Basic information
Public title
Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study
Acronym
Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study
Scientific Title
Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study
Scientific Title:Acronym
Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study
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 Autistic 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 24 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 Abberrant 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
24 weeks administration of intranasal oxytocin(24IU/day)
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 Disorder with behavioral problem
ABC-J irritability subscale 18points 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
Weight under 20kg
History of status epilepticus
possibility of pregnancy
Physical exhaustion and advanced inspection value or more
Target sample size
5
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
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/2017
ai-chie@po.bunbun.ne.jp
Sponsor or person
Institute
National Hospital Organization Hizen Psychiatric Center
Institute
Department
Personal name
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
Saga University
Name of secondary funder(s)
Saga University
IRB Contact (For public release)
Organization
Hizen Psychiatric Center
Address
160 mitsu yoshinogari Saga Japan
Tel
0952-52-3231
syomu2@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
| 2017 | Year | 09 | Month | 01 | 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
3
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because it is necessary to carry out again about Oxytocin concentration measurement(Add extraction home).
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
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 12 | Day |
Last modified on
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032790
