UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004966 |
|---|---|
| Receipt number | R000004027 |
| Scientific Title | A research of the brain function activity change after intranasal oxytocin administration |
| Date of disclosure of the study information | 2011/01/26 |
| Last modified on | 2012/08/27 12:17:46 |
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Basic information
Public title
A research of the brain function activity change after intranasal oxytocin administration
Acronym
brain function activity change by medication
Scientific Title
A research of the brain function activity change after intranasal oxytocin administration
Scientific Title:Acronym
brain function activity change by medication
Region
| Japan |
Condition
Condition
patients with neuropsychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore brain activity change during neuroimaging administrated by oxytocin or placebo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
magnetic resonance imaging (MRI)
near-infrared spectroscopy (NIRS)
eye-tracking
BIOPAC
blood sample
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
single intranasal oxytocin administration
Interventions/Control_2
single intranasal placebo administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with neuropsychiatric disorders and normal controls
Key exclusion criteria
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
60
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
Address
Matsuokashimoaizuki, Eiheiji, Fukui, JAPAN
TEL
Homepage URL
chiken@ml.ccns.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 | 01 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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 | 01 | Month | 26 | Day |
Last modified on
| 2012 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004027
