UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009075
Receipt No. R000010649
Scientific Title Effects of long-term administration of intranasal oxytocin on autism spectrum disorders
Date of disclosure of the study information 2012/11/01
Last modified on 2014/10/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of long-term administration of intranasal oxytocin on autism spectrum disorders
Acronym Effects of long-term administration of intranasal oxytocin on autism spectrum disorders
Scientific Title Effects of long-term administration of intranasal oxytocin on autism spectrum disorders
Scientific Title:Acronym Effects of long-term administration of intranasal oxytocin on autism spectrum disorders
Region
Japan

Condition
Condition Autism
Pervasive developmental disorders
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the effects on the behavior and side effects of long-term,daily administration of oxytocin on children with autism spectrum disorders.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The outcome measures are Abberant Behavior Checklist(ABC),Child Behavior Checklist(CBCL),Social Responsiveness Scale(SRS) completed by the caregivers and eye tracking tested before the administration of nasal oxytocin and at the end of each term(placebo or oxytocin).
In addition,we will analyze mutations of CD38.
Key secondary outcomes The second outocome measures are blood pressure,urine osmolarity,urine sodium concentration and oxytocin concentration of his second urine in the morning.They are measured every time the participant comes to the hospital during the trial.

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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In Arm 1, the subjects will receive 24IU/dose of intranasal oxytocin (Syntocinon Nasal Spray, NOVARTIS) administration twice daily for one month followed by one week washout period.Then they will receive the placebo (in the same type of containers that are used for oxytocin) twice daily for one month.
Interventions/Control_2 In Arm 2, the subjects will receive placebo (in the same type of containers that are used for oxytocin) twice daily for one month followed by one week washout period. Then they will receive 24IU/dose of intranasal oxytocin (Syntocinon Nasal Spray, NOVARTIS) administration twice daily for one month.
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
9 years-old >=
Gender Male
Key inclusion criteria All participants will be recruited from the outpatients of Osaka Univercity hospital if they meet the inclusion criteria as follows;1) having clinical diagnosis for autism spectrum disorders as assessed by use of DSM-4-TR (Text Revision of the Diagnostic and Statistical Manual of Mental Disorders,4th edition),and 2) having IQ between 35-75.
Key exclusion criteria We will exclude patients with cardio vascular disease.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masako Taniike
Organization Osaka University United Graduate School of Child Development
Division name Department of Child Development
Zip code
Address 2-2 Yamadaoka,Suita City,Osaka,Japan
TEL 06-6879-3863
Email masako@kokoro.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuko Hirata
Organization Osaka University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 2-2 Yamadaoka,Suita City,Osaka,Japan
TEL 06-6879-3863
Homepage URL
Email masako@kokoro.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 11 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
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 Terminated
Date of protocol fixation
2012 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 10 Day
Last modified on
2014 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010649

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.