UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011077
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mitsuruk@med.kanazawa-u.ac.jp

Sponsor
Institute Graduate School of Medical Science, Kanazawa University, Kanazawa University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012965

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.