Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Social Dysfunction and Brain Dysfunction in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903915
Recruitment Status : Unknown
Verified July 2013 by Jung-Sun Lee, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Jung-Sun Lee, Asan Medical Center

Brief Summary:
There were a few studies about the relationship of structural or functional abnormalities of brain and social cognitive dysfunctions in patients with schizophrenia. In addition, default network, which increases activity during mental explorations referenced to oneself including remembering, considering hypothetical social interactions, and thinking about one's own future, may be associated with social cognitive dysfunctions in patients with schizophrenia. Therefore, we will investigate the dysfunction of default network in patients with schizophrenia compared with healthy controls and the effect of default network dysfunctions on the social cognition in patients with schizophrenia.

Condition or disease
Schizophrenia Social Cognition

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Resting-state Magnetic Resonance Imaging of Brain in Patients With Schizophrenia Compared With Healthy Controls to Prove the Association Between Social Cognition Dysfunction and Abnormality of Brain Function
Study Start Date : July 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
Patients
Schizophrenia group
Control
Healthy control group



Primary Outcome Measures :
  1. Comparison of resting state functional MRI between schizophrenia patients and healthy controls [ Time Frame: Baseline ]

    After subjects are enrolled the study, functional MRI of the brain will be measured on rest. They will lie down in MRI machine and just open their eyes. There is no tasks for functional MRI.

    Unless the subject don't have any contraindication for MRI, they can be take MRI of brain safely.

    Resting-state functional brain MRI Data from subjects will be analysed statistically. We will use programs for image processing and statistical work, such as REST, Statistical Parametric Mapping(SPM), Freesurfer. For comparison between two groups, student t-test will be used.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients groups will be selected from psychiatric clinic in general hospital - Asan Medical Center.
Criteria

Patients group inclusion criteria:

  • Right-handed
  • Intelligent Quotient(IQ) above 80
  • can read and understand the informed consent
  • schizophrenia patients who was diagnosed from Structured Clinical Interview for Diagnostical and Statistical Manual of Mental Disorder 4th edition(DSM-IV, nonpatient version(SCID-NP) scales
  • patient who has had reality distortion symptoms (like delusion or hallucination) in 5 years

Control group inclusion criteria :

  • Right-handed
  • IQ above 80
  • do not have any diagnosis from SCID-NP scales
  • do not have any family members who have psychiatric disorder

Exclusion criteria:

  • have Illness which can affect brain structures and functions
  • can't be taken magnetic resonance imaging(MRI)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903915


Contacts
Layout table for location contacts
Contact: Jung-Sun Lee, MD 82 2 3010 3422 js_lee@amc.seoul.kr

Locations
Layout table for location information
Korea, Republic of
Department of psychiatry, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jung-Sun Lee, MD    82 2 3010 3422    js_lee@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jung-Sun Lee, MD Department of Psychiatry, Asan Medical Center

Publications:

Layout table for additonal information
Responsible Party: Jung-Sun Lee, Associate Professor, Department of Psychiatry, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01903915     History of Changes
Other Study ID Numbers: 07052012
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders