UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011077 |
|---|---|
| Receipt number | R000012965 |
| Scientific Title | Comparison of the cerebral function before and after the oxytocin administration for patients with autism spectrum disorder: open study using positron emission tomography and magnetoencephalography. |
| Date of disclosure of the study information | 2013/08/20 |
| Last modified on | 2015/08/30 20:15:19 |
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Basic information
Public title
Comparison of the cerebral function before and after the oxytocin administration for patients with autism spectrum disorder: open study using positron emission tomography and magnetoencephalography.
Acronym
Comparison of the cerebral function before and after the oxytocin administration for patients with autism spectrum disorder.
Scientific Title
Comparison of the cerebral function before and after the oxytocin administration for patients with autism spectrum disorder: open study using positron emission tomography and magnetoencephalography.
Scientific Title:Acronym
Comparison of the cerebral function before and after the oxytocin administration for patients with autism spectrum disorder.
Region
| Japan |
Condition
Condition
Autism spectrum disorder (high functioning)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With chronic administration of the oxytocin to the patients with autism spectrum disorder who does not have intelligence impairment, we investigate the influence on the serotonin system and the influence on a social cognitive function. The neurophysiological characterization of the patient who improves with oxytocin administration is also explored.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of the serotonin transporter density after the drug treatment (ten weeks).
Key secondary outcomes
Brain response to social stimuli recorded by MEG.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oxytocin nasal administration
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
- The patient diagnosed as the autism spectrum obstacle
- Male patient
- A patient aged 20 and over [ time of consent acquisition ]
- The patient whose intelligence quotient is 85 or more
Key exclusion criteria
- The patient who has hypersensitivity in oxytocin
- A patient with the past history of the head injury accompanied by the consciousness disorder for 5 minutes or more
- Patient with the history of substance-dependence.
-The patient who consumes water more than 3 liters a day.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kikuchi Mitsuru |
Organization
Kanazawa University
Division name
Department of Psychiatry and Neurobiology
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
0762652307
mitsuruk@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kikuchi Mitsuru |
Organization
Kanazawa University
Division name
Department of Psychiatry and Neurobiology
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
0762652307
Homepage URL
mitsuruk@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kanazawa University, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kiban-B from MEXT
Strategic Research Program for Brain Sciences from MEXT
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
| 2013 | Year | 08 | Month | 20 | 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
| 2013 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | 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
| 2013 | Year | 06 | Month | 29 | Day |
Last modified on
| 2015 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012965
