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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007122
Receipt No. R000008388
Scientific Title A randomized, double-blind and cross-over trial to examine effects of continuous administration of intranasal oxytocin on social dysfunction in subjects with autism spectrum disorders
Date of disclosure of the study information 2012/02/01
Last modified on 2013/05/01

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Basic information
Public title A randomized, double-blind and cross-over trial to examine effects of continuous administration of intranasal oxytocin on social dysfunction in subjects with autism spectrum disorders
Acronym A preliminary trial to examine therapeutic effects of continuous administration of intranasal oxytocin in subjects with autism spectrum disorders
Scientific Title A randomized, double-blind and cross-over trial to examine effects of continuous administration of intranasal oxytocin on social dysfunction in subjects with autism spectrum disorders
Scientific Title:Acronym A preliminary trial to examine therapeutic effects of continuous administration of intranasal oxytocin in subjects 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 This trial is aimed to test the safety of continuous administration of intranasal oxytocin and to test its efficacy and estimate the effect size for the following future goals: 1) To examine therapeutic effect of continuous administration of intranasal oxytocin on autistic symptoms, 2) To examine cognitive and neural correlates of the therapeutic effect by psychological paradigms and functional MRI, and 3) To identify genetic factors associated with the individual differences in the therapeutic effects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Changes from baseline to post-administration (6 and 12 weeks after the start) on the ADOS (Autism Diagnostic Observation Schedule) and CARS 2 (Childhood Autism Rating Scale 2) .
Key secondary outcomes Psychological paradigms to test social cognition and behavior, and changes in eye-tracking and functional-MRI signal during the psychological paradigms.
Metabolites levels in the medial prefrontal cortex measured with proton magnetic resonance spectroscopy.
Scores of Autism Spectrum Quotient, Social Responsiveness Scale, Clinical Global Impressions, Global Assessment of Functioning, Repetitive Behavior Scale, Quality of Life questionaire, State–Trait Anxiety Inventory, Center for Epidemiologic Studies Depression Scale, Barratt Impulsiveness Scale.

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

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. followed by intranasal administration of placebo for twice per day, six weeks.
Interventions/Control_2 Intranasal administration of placebo for twice per day, six weeks, followed by administration of 48 IU/day intranasal oxytocin 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 with autistic disorder or Asperger's disorder or pervasive developmental disorder not-otherwise-specified
2) Verbal IQ above 85 and Full IQ above 80 measured with Wechsler Ault Intelligent Scale-Revised
Key exclusion criteria 1) History of allergy for oxytocin
2) History of seizures or traumatic brain injury with any known cognitive consequences or loss of consciousness for more than five minutes
3) History of substance abuse or addiction
4) Current instability of comorbid psychiatric symptoms
5) Having contraindication of MR-scanning
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Yamasue
Organization University of Tokyo Hospital
Division name Department of Neuropsychiatry
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokyo Hospital
Division name Clinical Research Center
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Department of Neuropsychiatry, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Showa University School of Medicine
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 東京大学医学部附属病院、昭和大学医学部附属烏山病院

Other administrative information
Date of disclosure of the study information
2012 Year 02 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 Completed
Date of protocol fixation
2011 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2013 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 23 Day
Last modified on
2013 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008388

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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