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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044026
Receipt No. R000050273
Scientific Title Autistic traits and social cognition in patients with schizophrenia
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/23

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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