UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005211 |
|---|---|
| Receipt number | R000005901 |
| Scientific Title | A research of therapy evaluation to prosocial behavior after intranasal oxytocin administration. |
| Date of disclosure of the study information | 2011/03/08 |
| Last modified on | 2014/09/08 09:11:15 |
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Basic information
Public title
A research of therapy evaluation to prosocial behavior after intranasal oxytocin administration.
Acronym
A research of therapy evaluation of oxytocin efficacy.
Scientific Title
A research of therapy evaluation to prosocial behavior after intranasal oxytocin administration.
Scientific Title:Acronym
A research of therapy evaluation of oxytocin efficacy.
Region
| Japan |
Condition
Condition
autism spectrum disorders (ASD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are
1. to evaluate prosocial behavior after continuous administration of intranasal oxytocin
and
2. to evaluate safety after continuous administration of intranasal oxytocin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Global Impression (CGI; CGI-Severity scale, CGI-Improvement scale) Interaction Rating Scale Advanced (IRSA)
Key secondary outcomes
Blood smple (plasma oxytocin concentration, sex hormones, oxytocin receptor polymorphism)
aberrant behavior checklist (ABC)
Zung self-rating depression scale (Zung-SDS)
state-trait anxiety inventory (STAI)
The 20-item Toronto Alexithymia Scale (TAS-20)
eye-tracking
BIOPAC
magnetic resonance imaging (MRI: functional MRI, T1 weighted images)
Near-infrared spectroscopy (NIRS)
Electroencephalogram\
Stabilometer
Safety
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous administration of placebo
Interventions/Control_2
Continuous administration of intranasal low-dose oxytocin
Interventions/Control_3
Continuous administration of intranasal high-dose oxytocin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with autism spectrum disorders (ASD) based on the classifications in the diagnostic and statistical manual of mental disorders (DSM-IV) and standardized criteria using the diagnostic interview for social and communication disorders (DISCO).
Key exclusion criteria
1. Children less than 15 years old.
2. Participants were excluded if they had a history of major medical or neurological illness including epilepsy, significant head trauma, or a lifetime history of alcohol or drug dependence.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Kosaka |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
Address
Matsuokashimoaizuki, Eiheiji, Fukui, JAPAN
TEL
0776-61-3111
hirotaka@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Terazawa |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
IRB
Zip code
Address
Matsuokashimoaizuki, Fukui, JAPAN
TEL
0776-61-3111
Homepage URL
chiken@ml.cii.u-fukui.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
| 2011 | Year | 03 | Month | 08 | 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 | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | 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
| 2011 | Year | 03 | Month | 08 | Day |
Last modified on
| 2014 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005901
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
