Social Dysfunction and Brain Dysfunction in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01903915
• Other study ID #: 07052012
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2013
• Last updated: July 17, 2013
• Start date: July 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2013
• Source: Asan Medical Center
• Contact: Jung-Sun Lee, MD
• Phone: 82 2 3010 3422
• Email: js_lee[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia
• Social Cognition

Locations

Country	Name	City	State
Korea, Republic of	Department of psychiatry, Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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. — View Citation

Barros M, Dempster EL, Illott N, Chabrawi S, Maior RS, Tomaz C, Silva MA, Huston JP, Mill J, Müller 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. — View Citation

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. — View Citation

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. Epub 2005 Dec 11. — View Citation

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. Erratum in: Am J Psychiatry. 2007 Jul;164(7):1123. — View Citation

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. — View Citation

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

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. — View Citation

Newton DE, Thornton C, Konieczko KM, Jordan C, Webster NR, Luff NP, Frith CD, Doré 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No