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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003812
Receipt No. R000004599
Scientific Title Evaluation of efficacy of intranasal oxytocin spray on children with autistic disorder
Date of disclosure of the study information 2010/07/01
Last modified on 2014/08/07

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Basic information
Public title Evaluation of efficacy of intranasal oxytocin spray on children with autistic disorder
Acronym Intranasal oxytocin spray on children with autistic disorder
Scientific Title Evaluation of efficacy of intranasal oxytocin spray on children with autistic disorder
Scientific Title:Acronym Intranasal oxytocin spray on children with autistic disorder
Region
Japan

Condition
Condition Autistic disorder
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim of this project is to evaluate the possibility of oxytocin as a novel therapy for autism by its administration via intranasal spray for six months on children with autistic disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behavioral Evaluation of children by child behavior checklist(CBCL), autism diagnostic observation schedule(ADOS), childhood autism rating scale(CARS) will be performed before and 6 and 12 months after the initiation of therapy.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oxytocin is administered twice daily via intranasal spray. First, after the examinees have accustomed to the procedure of intranasal placebo spray for 1-2 weeks, doses administered are increased from 8IU, 16 IU to 24 IU per dose every two months. Washout period when examinees receive placebo administration is designed before dose-up.
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
10 years-old <=
Age-upper limit
15 years-old >
Gender Male
Key inclusion criteria Children who are seen in the pediatric outpatient clinic in Osaka University Hospital under the diagnosis of autism or autistic disorder.
Key exclusion criteria 1. Boys without development of secondary sexual characteristics
2. Comorbid heart disorders
3. In cases where the attending doctors judged the participation to the study as inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masako Taniike
Organization Osaka University
Division name United Graduate School of Child Development
Zip code
Address 2-2 Yamadaoka, Suita
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Tachibana
Organization Osaka University
Division name United Graduate School of Child Development
Zip code
Address 2-2 Yamadaoka, Suita
TEL
Homepage URL
Email m-tach@kokoro.med.osaka-u.ac.jp

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

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2010 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, Oishi M, Kimura T, Onaka T, Ozono K, Taniike M. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):123-7. 
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 Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 23 Day
Last modified on
2014 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004599

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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