UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043777
Receipt number R000049332
Scientific Title The Evaluation study for Social Cognition Measures in Japan
Date of disclosure of the study information 2021/04/01
Last modified on 2023/04/04 13:22:09

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Basic information

Public title

The Evaluation study for Social Cognition Measures in Japan

Acronym

ESCoM

Scientific Title

The Evaluation study for Social Cognition Measures in Japan

Scientific Title:Acronym

ESCoM

Region

Japan


Condition

Condition

Schizophrenia,
Healthy control

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The main objectives of the present study are to assess the nine measures selected by the domestic expert panel simultaneously in the same patients and to examine the relative merits of these nine social cognition measures by calculating psychometric indicators.
In calculating several psychosometric indicators in this study, we will focus on whether social cognition measures can independently predict social function.

Basic objectives2

Others

Basic objectives -Others

Measures' reliability, validity, and correlations with social function; relation of each measure with patient background, psychiatric symptoms, defeatist performance belief, and gut microbiota

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Bell Lysaker Emotion Recognition Task(BLEART)
Penn Emotion Recognition Task (ER40)
Facial Emotion Selection Test (FEST)
The Hinting Task (Hinting)
Metaphor and sarcasm scenario test (MSST)
Ambiguous Intentions and Hostility Questionnaire (AIHQ)
The Intentionality Bias Task (IBT)
The Social Attribution Task (SAT)
Biological motion task (BM)

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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with schizophrenia
1. The patients with schizophrenia in this study will be outpatients at the National Center of Neurology and Psychiatry, Hokkaido University Hospital, and Toho University Omori Medical Center.
2. primary diagnosis of schizophrenia based on the DSM-V at the time of assessment
3. no hospitalization in the previous 2 months, no changes in prescriptions in the past 6 weeks, and no changes in prescription dosage in the past 2 weeks
4. age 20-59 years at the time of obtaining informed consent
5. written informed consent to participate in the study based on an understanding of its objective and content (capacity to consent).

Healthy Control
1. age 20-59 years at the time of study participation
2. confirmation of no diagnoses of mental disorders at the time of study participation
3. written informed consent to participate in the study.

Key exclusion criteria

Patients with schizophrenia
1. physical/mental disorders that prevent implementation of measures during study participation
2. insufficient Japanese language ability to respond to self-reported psychological measures based on a sufficient understanding of the questions
3. being deemed ineligible to participate for any other reason by an attending physician or study staff.

Healthy Control
1. physical/mental disorders that prevent implementation of measures during study participation
2. insufficient Japanese language ability to respond to self-reported psychological measures based on a sufficient understanding of the questions
3. being deemed ineligible to participate for any other reason by an attending physician or study staff.

Target sample size

210


Research contact person

Name of lead principal investigator

1st name Ryo
Middle name
Last name Okubo

Organization

National Center of Neurology and Psychiatry

Division name

Department of Clinical Epidemiology, Translational Medical Center

Zip code

187-8551

Address

4-1-1 Ogawahigashi Kodaira, Tokyo, Japan

TEL

042-341-2711

Email

ryo-okubo@ncnp.go.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Okubo

Organization

National Center of Neurology and Psychiatry

Division name

Department of Clinical Epidemiology, Translational Medical Center

Zip code

187-8551

Address

4-1-1 Ogawahigashi Kodaira, Tokyo, Japan

TEL

042-341-2711

Homepage URL


Email

ryo-okubo@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center of Neurology and Psychiatry

Address

4-1-1 Ogawahigashi Kodaira, Tokyo, Japan

Tel

042-341-2711

Email

rinri-jimu@ncnp.go.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



Other administrative information

Date of disclosure of the study information

2021 Year 04 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

Completed

Date of protocol fixation

2020 Year 11 Month 02 Day

Date of IRB

2020 Year 12 Month 07 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

pending


Management information

Registered date

2021 Year 03 Month 29 Day

Last modified on

2023 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049332


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name