UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015264 |
|---|---|
| Receipt number | R000017703 |
| Scientific Title | A multicenter, parallel group, placebo-controlled, double blind, confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders |
| Date of disclosure of the study information | 2014/10/30 |
| Last modified on | 2017/02/16 16:11:06 |
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Basic information
Public title
A multicenter, parallel group, placebo-controlled, double blind, confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders
Acronym
A multicenter confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders
Scientific Title
A multicenter, parallel group, placebo-controlled, double blind, confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders
Scientific Title:Acronym
A multicenter confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders
Region
| Japan |
Condition
Condition
Autism spectrum disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1) To confirm efficacy of intranasal oxytocin on a core symptom of autism spectrum disorders, deficit in social reciprocity, in parallel group comparison
2) To test time-course change in the efficacy for consideration of optimized treatment duration
3) To develop molecular bio-markers for prediction of treatment outcomes and uncovering the mechanisms of therapeutic effect
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in scores of social reciprocity in Autism Diagnostic Observation Schedule administered just before and after double blind treatment period
Key secondary outcomes
Changes in scores of communication and restricted and repetitive behavior in Autism Diagnostic Observation Schedule administered just before and after double blind treatment period
State and Trait Anxiety Inventory and Center for Epidemiologic Studies Depression Scale assessed just before and after double blind treatment period
DNA-methylations analyzed from whole-genome analysis using peripheral bloods collected just before and after double blind treatment period
Eye gaze assessed just before and after double blind treatment period
Facial and voice expressions analyzed from videos recorded in every two weeks during trial period
Clinical Global Impression and Global Assessment of Functioning assessed in every two weeks during trial period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 48 IU/day intranasal oxytocin for twice per day, six weeks
Interventions/Control_2
Intranasal administration of placebo for twice per day, six weeks
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
1) Diagnosed as autistic disorder or Asperger's disorder or pervasive developmental disorder not-otherwise-specified based on DSM-IV-TR
2) Exceeded cutoff for qualitative abnormalities in reciprocal social interaction (Domain A) in Autism Diagnostic Interview-Revised
3) Verbal IQ above 85 and Full IQ above 80 measured with Wechsler Adult Intelligent Scale-III
Key exclusion criteria
1) Primary psychiatric diagnosis other than inclusion criteria 1)
2) Current instability due to a comorbid psychiatric diagnosis
3) History of changes in medications or medication doses of psychotropics within one month of randomization
4) Under current treatment with psychotropics more than two categories
5) Under current treatment with atomoxetine or methylphenidate
6) History of continual treatment of oxytocin
7) History of sensitivity to oxytocin
8) History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes
9) History of alcoholics or substance abuse or addiction
Target sample size
114
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Yamasue |
Organization
The University of Tokyo Hospital
Division name
Department of Neuropsychiatry
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
yamasue-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Yamasue |
Organization
The University of Tokyo Hospital
Division name
Department of Neuropsychiatry
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yamasue-tky@umin.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The Strategic Research Program for Brain Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa University Hospital, Nagoya University Hospital, University of Fukui Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
P2014032-11X
Org. issuing International ID_1
The University of Tokyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
金沢大学附属病院（石川県）、名古屋大学医学部附属病院（愛知県）、福井大学医学部附属病院（福井県）、東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 24 | 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
| 2014 | Year | 09 | Month | 26 | Day |
Last modified on
| 2017 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017703
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