NCT01903915

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

2.4 years

First QC Date

July 10, 2013

Last Update Submit

July 17, 2013

Conditions

SchizophreniaSocial Cognition

Outcome Measures

Primary Outcomes (1)

  • Comparison of resting state functional MRI between schizophrenia patients and healthy controls

    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.

    Baseline

Study Arms (2)

Patients

Schizophrenia group

Control

Healthy control group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients groups will be selected from psychiatric clinic in general hospital - Asan Medical Center.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of psychiatry, Asan Medical Center

Seoul, Seoul, 138-736, South Korea

RECRUITING

Related Publications (11)

  • Garrity AG, Pearlson GD, McKiernan K, Lloyd D, Kiehl KA, Calhoun VD. Aberrant "default mode" functional connectivity in schizophrenia. Am J Psychiatry. 2007 Mar;164(3):450-7. doi: 10.1176/ajp.2007.164.3.450.

    PMID: 17329470BACKGROUND

  • Hans S, Vaissiere J, Crevier-Buchman L, Laccourreye O, Brasnu D. Aerodynamic and acoustic parameters in CO2 laser posterior transverse cordotomy for bilateral vocal fold paralysis. Acta Otolaryngol. 2000 Mar;120(2):330-5. doi: 10.1080/000164800750001206.

    PMID: 11603801BACKGROUND

  • Amodio DM, Kubota JT, Harmon-Jones E, Devine PG. Alternative mechanisms for regulating racial responses according to internal vs external cues. Soc Cogn Affect Neurosci. 2006 Jun;1(1):26-36. doi: 10.1093/scan/nsl002.

    PMID: 18985098BACKGROUND

  • Newton DE, Thornton C, Konieczko KM, Jordan C, Webster NR, Luff NP, Frith CD, Dore CJ. Auditory evoked response and awareness: a study in volunteers at sub-MAC concentrations of isoflurane. Br J Anaesth. 1992 Aug;69(2):122-9. doi: 10.1093/bja/69.2.122.

    PMID: 1389813BACKGROUND

  • Klee EW, Finlay JA, McDonald C, Attewell JR, Hebrink D, Dyer R, Love B, Vasmatzis G, Li TM, Beechem JM, Klee GG. Bioinformatics methods for prioritizing serum biomarker candidates. Clin Chem. 2006 Nov;52(11):2162-4. doi: 10.1373/clinchem.2006.072868. No abstract available.

    PMID: 18061989BACKGROUND

  • Tan HY, Chen Q, Goldberg TE, Mattay VS, Meyer-Lindenberg A, Weinberger DR, Callicott JH. Catechol-O-methyltransferase Val158Met modulation of prefrontal-parietal-striatal brain systems during arithmetic and temporal transformations in working memory. J Neurosci. 2007 Dec 5;27(49):13393-401. doi: 10.1523/JNEUROSCI.4041-07.2007.

    PMID: 18057197BACKGROUND

  • Keefe RS. Cognitive deficits in patients with schizophrenia: effects and treatment. J Clin Psychiatry. 2007;68 Suppl 14:8-13.

    PMID: 18284272BACKGROUND

  • Fox MD, Snyder AZ, Zacks JM, Raichle ME. Coherent spontaneous activity accounts for trial-to-trial variability in human evoked brain responses. Nat Neurosci. 2006 Jan;9(1):23-5. doi: 10.1038/nn1616. Epub 2005 Dec 11.

    PMID: 16341210BACKGROUND

  • Bogialli S, Curini R, Di Corcia A, Nazzari M, Sergi M. Confirmatory analysis of sulfonamide antibacterials in bovine liver and kidney: extraction with hot water and liquid chromatography coupled to a single- or triple-quadrupole mass spectrometer. Rapid Commun Mass Spectrom. 2003;17(11):1146-56. doi: 10.1002/rcm.1031.

    PMID: 12772270BACKGROUND

  • Rieger JW, Kim A, Argyelan M, Farber M, Glazman S, Liebeskind M, Meyer T, Bodis-Wollner I. Cortical functional anatomy of voluntary saccades in Parkinson disease. Clin EEG Neurosci. 2008 Oct;39(4):169-74. doi: 10.1177/155005940803900404.

    PMID: 19044213BACKGROUND

  • Barros M, Dempster EL, Illott N, Chabrawi S, Maior RS, Tomaz C, Silva MA, Huston JP, Mill J, Muller CP. Decreased methylation of the NK3 receptor coding gene (TACR3) after cocaine-induced place preference in marmoset monkeys. Addict Biol. 2013 May;18(3):452-4. doi: 10.1111/j.1369-1600.2011.00409.x. Epub 2011 Nov 9.

    PMID: 22070124BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jung-Sun Lee, MD

    Department of Psychiatry, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Sun Lee, MD

CONTACT

82 2 3010 3422js_lee@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychiatry

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 19, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

July 19, 2013

Record last verified: 2013-07

Locations

KR(1)