UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007122 |
|---|---|
| Receipt number | 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 16:25:43 |
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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
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
Sponsor or person
Institute
Department of Neuropsychiatry, Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008388
