UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044026
Receipt number 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 20:42:01

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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 or person

Institute

Department of psychiatry, Chiba University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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