UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017876 |
|---|---|
| Receipt number | 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 | 2023/12/21 15:53:04 |
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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 | Masako |
| Middle name | |
| Last name | Taniike |
Organization
Osaka University
Division name
Department of Child Development
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka, Japan
TEL
0668793863
masako@kokoro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Taniike |
Organization
Osaka University
Division name
Department of Child Development
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka, Japan
TEL
0668793863
Homepage URL
masako@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
United Graduate School of Child Development, Osaka University
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6879-3345
nakamura-mari-m@office.osaka-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
1
Results
Only one child was recruited with any apparent adverse events. It was impossible to analyze the therapeutic effectiveness from one case. This study was discontinued because of the sudden unavailability of the researchers involved in this study.
Results date posted
| 2023 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1. Children who were diagnosed as autism spectrum disorder using the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and Autism Diagnostic Observation Schedule (ADOS)
2. Boys
3. Recent evaluation within the last one year revealed the children haaving mild to moderate intellectual deficit with DQ/IQ 35 - 75
4. Age of 6 to 10 years old, or the 1st ~the 4th grader of the elementary school
5. Informed consent was obtained from caregivers of the children.
Participant flow
1. Post the poster documenting the contents of this clinical study on the wall of the pediatric clinic of Osaka University.
2. Recruit directly the caregivers of the children who are possible candidates of this study.
Adverse events
None was recognized in one case completing the study.
Outcome measures
We set the total Social Responsiveness Scale (SRS) score as the primary endpoint and GAF score, SRS subscale score, total and externalizing/internalizing subscale scores of child behavioral checkllist (CBCL), and Abberant Behavior Checklist (ABC) as secondary endpoint.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 08 | Day |
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
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020712
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