UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007250 |
|---|---|
| Receipt number | 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 10:27:32 |
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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
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
Sponsor or person
Institute
Research Center for Child Mental Development, Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008548
