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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015264
Receipt No. 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

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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
Email 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
Email yamasue-tky@umin.ac.jp

Sponsor
Institute Department of Neuropsychiatry, The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017703

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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