UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathological study of Autism using PET
Title of the study (Brief title)	Pathological study of Autism using PET
Region	Japan

Condition
Condition	Autism
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Serotonin transporter, activated microglia
Basic objectives2	Others
Basic objectives -Others	Binding potential of PET
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Binding potential of PET
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	35 years-old >=
Gender	Male and Female
Key inclusion criteria	Autism
Key exclusion criteria	Other disorder except psychiatric disorder
Target sample size	10

Research contact person
Name of lead principal investigator	Masamichi Yokokura
Organization	Hamamatsu University School of Medicine
Division name	Psychiatry
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2111
Email	ykkr@hama-med.ac.jp

Public contact
Name of contact person	Masamichi Yokokura
Organization	Hamamatsu University School of Medicine
Division name	Psychiatry
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2111
Homepage URL
Email	ykkr@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	observational study

Management information
Registered date	2016 Year 06 Month 18 Day
Last modified on	2017 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026265