UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003812 |
|---|---|
| Receipt number | 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 14:03:38 |
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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
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
m-tach@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University United Graduate School of Child Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004599
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
