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
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
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
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
