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A two-phased study to determine the neural bases of negative symptoms in schizophrenia

Status Approved

First Submitted Date

2017/04/27
Registered Date

2017/05/24
Last Updated Date

2017/11/08

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002337
Unique Protocol ID	4-2015-0148
Public/Brief Title	The neural bases of negative symptoms in schizophrenia
Scientific Title	A two-phased study to determine the neural bases of negative symptoms in schizophrenia
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	4-2015-0148
Approval Date	2015-04-12
Institutional Review Board Name	Yonsei University Health System, Severance Hospital, Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	YoungChul Jung
Title	MD
Telephone	+82-2-2228-1620
Affiliation	Yonsei University Health System, Severance Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	JoonHyung Kim
Title	MD
Telephone	+82-2-2019-3340
Affiliation	Yonsei University Health System, Severance Hospital
Address	Eonju-ro 63gil 20, Gangnam Severance Hospital Center for Future Medicine, Seoul, Korea, Republic of
Contact Person for Updating Information
Name	Hesun Erin Kim
Title	MS
Telephone	+82-2-2019-3340
Affiliation	Yonsei University Health System, Gangnam Severance Hospital
Address	Eonju-ro 63gil 20, Gangnam Severance Hospital Center for Future Medicine, Seoul, Korea, Republic of

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2015-05-12 Actual
Target Number of Participant	160
Primary Completion Date
Study Completion Date
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2015-05-12 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University Health System, Severance Hospital
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	The negative symptoms of schizophrenia involve deficits in emotional expression and motivation. These deficits are associated with poor functional outcome and quality of life, as well as poor response to treatment. Therefore, it is important to understand the neural correlates of negative symptom in schizophrenia for uncovering the pathophysiological mechanisms and developing targeted interventions. To investigate neural bases of the anhedonia in negative symptoms, 40 adult schizophrenia patients and 40 healthy control individuals will be recruited through advertisement at a local hospital, and we are going to conduct the decision-making task about price and purchase of clothing, and related pleasure experience during fMRI scanning. Meanwhile, to identify the neural bases of amotivation, intrinsic and extrinsic motivation for daily social and recreational activities will be evaluated during fMRI scanning. In addition to the fMRI task, assessments for measuring the negative symptom will be administered. Imaging data will be first analyzed to identify regions compared between patients and healthy control. Second, the correlation between scores of negative symptom scale and functional activation will be conducted.

Study Summary Information

Lay Summary

The negative symptoms of schizophrenia involve deficits in emotional expression and motivation. These deficits are associated with poor functional outcome and quality of life, as well as poor response to treatment. Therefore, it is important to understand the neural correlates of negative symptom in schizophrenia for uncovering the pathophysiological mechanisms and developing targeted interventions.
To investigate neural bases of the anhedonia in negative symptoms, 40 adult schizophrenia patients and 40 healthy control individuals will be recruited through advertisement at a local hospital, and we are going to conduct the decision-making task about price and purchase of clothing, and related pleasure experience during fMRI scanning. Meanwhile, to identify the neural bases of amotivation, intrinsic and extrinsic motivation for daily social and recreational activities will be evaluated during fMRI scanning. In addition to the fMRI task, assessments for measuring the negative symptom will be administered.
Imaging data will be first analyzed to identify regions compared between patients and healthy control. Second, the correlation between scores of negative symptom scale and functional activation will be conducted.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-control
Time Perspective	Prospective
Target Number of Participant	160
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label schizophrenia
Cohort/ Group 1	Cohort/Group Description brain activity and its relationship with clinical variables
Cohort/ Group 2	Cohort/Group Label Healthy control
Cohort/ Group 2	Cohort/Group Description brain activity and its relationship with clinical variables
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	A male and female aged between 20 - 50
Sampling Method	Probablility sampling
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F20.9)Schizophrenia, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~50Year
	Description 1. diagnosed with schizophrenia 2. understanding a detailed explanation of the study 3. without in an acute phase of psychosis (as determined by the Positive and Negative Syndrome Scale score below 80 points) 4. predominantly right-handed (as determined by the Edinburgh handedness inventory)
Exclusion Criteria	1. the presence of a neurological, psychiatric or significant medical illness, and a history of current or past substance abuse or dependence 2. in case of schizophrenia, other mental diseases 3. in case of healthy controls, a history of current or past psychiatric disorder
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	comparison of brain activity between schizophrenia and healthy control
Timepoint	during fMRI task
Secondary Outcome(s) 1
Outcome	association of percent signal changes with clinical variables
Timepoint	during fMRI task

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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