UMIN-CTR Clinical Trial

Basic information
Public title	Autistic traits and social cognition in patients with schizophrenia
Acronym	Autistic traits and social cognition in patients with schizophrenia
Scientific Title	Autistic traits and social cognition in patients with schizophrenia
Scientific Title:Acronym	Autistic traits and social cognition in patients with schizophrenia
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Hepato-biliary-pancreatic medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate autistic traits and social cognition in patients with schizophrenia including patients with treatment-resistant schizophrenia
Basic objectives2	Others
Basic objectives -Others	General cognitive function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Autistic traits and social cognition
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Individuals who meet the criteria for schizophrenia or schizoaffective disorder with DSM-5 Healthy subjects
Key exclusion criteria	Individuals with any other mental disorder Individuals with serious complication Individuals without disease notification Individuals with pregnancy/possibility of pregnancy, or lactating Individuals with suicidal ideation
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Masaomi Middle name Last name Iyo
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL	043-222-7171
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Nakata
Organization	Chiba University Hospital
Division name	Psychiatry
Zip code	260-8677
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	nakata.y@chiba-u.jp

Sponsor
Institute	Department of psychiatry, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Grant in-Aid for Scientific Research(KAKENHI)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba University research support division
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
Tel	043-226-2462
Email	igaku-rinri@office.chiba-u.jp

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	千葉大学医学部附属病院(千葉)

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 18 Day
Date of IRB	2021 Year 03 Month 18 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	-

Management information
Registered date	2021 Year 04 Month 23 Day
Last modified on	2021 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050273