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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043777
Receipt No. 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 2021/03/29

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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
Institute National Center of Neurology and Psychiatry
Institute
Department

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 Preinitiation
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
2021 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.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


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