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

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 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


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

Value
https://center6.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