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

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/2017

Email

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

Email

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


Research Plan
Registered date File name
2018/02/11 (FIX)佐賀大学実施計画書長期試験2017.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name