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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007250
Receipt No. R000008548
Scientific Title A randomized, double-blind, placebo-controlled, cross-over trial of oxytocin in patients with autism spectrum disorder
Date of disclosure of the study information 2012/02/09
Last modified on 2016/03/14

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Basic information
Public title A randomized, double-blind, placebo-controlled, cross-over trial of oxytocin in patients with autism spectrum disorder
Acronym A controlled trial of oxytocin in patients with autism spectrum disorder
Scientific Title A randomized, double-blind, placebo-controlled, cross-over trial of oxytocin in patients with autism spectrum disorder
Scientific Title:Acronym A controlled trial of oxytocin in patients with autism spectrum disorder
Region
Japan

Condition
Condition autism spectrum disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This trial is aimed to examine the efficacy and the safety of continuous administration of intranasal oxytocin in mentally retarded patients with autism spectrum disorder.
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 every two weeks on the Childhood Autism Rating Scale
Key secondary outcomes Changes from baseline to post-administration every two weeks on the Clinical Global Impressions, Aberrant Behavior Checklist, Global Assessment of Functioning, plasma oxytocin concentration and Interaction Rating Scale Advanced

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intranasal administration of 16 IU/day oxytocin (Syntocinon, Novartis) for twice per day, eight weeks, followed by intranasal administration of placebo for twice per day, eight weeks.
Interventions/Control_2 Intranasal administration of placebo for twice per day, eight weeks, followed by intranasal administration of 16 IU/day oxytocin (Syntocinon, Novertis) for twice per day, eight 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
15 years-old <=
Age-upper limit
45 years-old >
Gender Male
Key inclusion criteria 1. Diagnosed as having autistic disorder or pervasive developmental disorder not otherwise specified based on Diagnostic and Statistical Manual of Mental Disorders Forth edition Text revision using Diagnostic Interview for Social and Communication Disorders
2. Intelligence Quotient below 75
3. Possible to be drew blood from a vein
Key exclusion criteria 1. History of allergy for oxytocin
2. History of traumatic brain injury with loss of consciousness for more than 5 minutes
3. Diagnosed as having substance dependence or history of substance dependence
4. History of water intoxication
5. Routinely severe polydipsia
6. Clinical judgment of ineligility for some reason
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Munesue
Organization Kanazawa University
Division name Research Center for Child Mental Development
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa,
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University Hospital
Division name Center for Clinical Research Management
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Research Center for Child Mental Development, Kanazawa University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2013 Year 10 Month 25 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 02 Month 08 Day
Last modified on
2016 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008548

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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