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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017876
Receipt No. R000020712
Scientific Title Effects of long-term administration of intranasal oxytocin in children with autism spectrum disorder
Date of disclosure of the study information 2015/06/19
Last modified on 2015/11/10

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Basic information
Public title Effects of long-term administration of intranasal oxytocin in children with autism spectrum disorder
Acronym Effects of long-term administration of intranasal oxytocin in children with autism spectrum disorder
Scientific Title Effects of long-term administration of intranasal oxytocin in children with autism spectrum disorder
Scientific Title:Acronym Effects of long-term administration of intranasal oxytocin in children with autism spectrum disorder
Region
Japan

Condition
Condition Autism spectrum disorder
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of long-term intranasal administration of oxytocin on the behavior in male children with autism spectrum disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SRS total score
Adverse events
Blood pressure,body weight
Serum Na concentration, serum osmolality
Key secondary outcomes Global Assessment of Functioning (GAF)
SRS subscale scores
CBCL total score, externalizing score, internalizing score, subscale scores.
ABC-J subscale scores

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After 1-2 weeks of practice period to get used to the procedure of intranasal administration, the placebo is first administered to those assigned to group A for one month. After a washout period of one week, the oxytocin trial (24IU/dose twice dairy) is administered to each participant for one month. Finally, a post- intervention checkup is performed 1 month after the end of the cross over phase.
Interventions/Control_2 After 1-2 weeks practice period to get used to the procedure of intranasal administration, oxytocin (24IU/dose twice dairy) is first administered to those assigned to group B for one month. After a washout period of 1 week, the placebo is administered to each participant for one month. Finally, a post- intervention checkup is performed 1 month after the end of the cross over phase.
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
6 years-old <=
Age-upper limit
10 years-old >=
Gender Male
Key inclusion criteria 1. The diagnosis for ASD was made based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and further confirmed by the Autism Diagnostic Observation Schedule (ADOS) at Osaka university hospital.
2. Male
3. Having IQ/DQ between 35-75 assessed in the preceding one year.
4. The age of six - ten years old (1st-4th grade at elementary school) at the day written informed consent for participation is obtained.
5. Parents or legal guardians of the participant provide written informed consent for participation.
Key exclusion criteria 1. Comorbid cardiovascular disease or renal disease
2. History of allergy to oxytocin
3. Female
4. Patients who has used the intranasal oxytocin in the past
5. Responsible doctors judged the trial inappropriate for the patient.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masako Taniike
Organization Osaka University
Division name Department of Child Development
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka, Japan
TEL 0668793863
Email masako@ped.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masako Taniike
Organization Osaka University
Division name Department of Child Development
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka, Japan
TEL 0668793863
Homepage URL
Email masako@ped.med.osaka-u.ac.jp

Sponsor
Institute United Graduate School of Child Development, Osaka University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 06 Month 19 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 08 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 22 Day
Last follow-up date
2015 Year 09 Month 08 Day
Date of closure to data entry
2015 Year 10 Month 29 Day
Date trial data considered complete
2015 Year 10 Month 29 Day
Date analysis concluded
2015 Year 12 Month 28 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 11 Day
Last modified on
2015 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020712

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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