SchizophreniaNCT01903915
Social Dysfunction and Brain Dysfunction in Patients With Schizophrenia
An observational study of Schizophrenia and Social Cognition, run by Asan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Social Cognition
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients groups will be selected from psychiatric clinic in general hospital - Asan Medical Center.
Who may be able to join
None listed.
Who cannot join
- have Illness which can affect brain structures and functions
- can't be taken magnetic resonance imaging(MRI)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of psychiatry, Asan Medical Center
Seoul, Seoul, 138-736
Jung-Sun Lee, MD, 82 2 3010 3422, js_lee@amc.seoul.kr
About this study
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
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.
- Conditions
- Schizophrenia, Social Cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Schizophrenia group | |
| Control | Healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Sun Lee, Asan Medical Center
- Investigators
- Jung-Sun Lee, MD, Principal investigator, Department of Psychiatry, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903915
- Sponsor's protocol ID
- 07052012
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17329470Hans 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.
PubMed 11603801Amodio 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.
PubMed 18985098Newton 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.
PubMed 1389813Klee 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.
PubMed 18061989Tan 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.
PubMed 18057197Keefe RS. Cognitive deficits in patients with schizophrenia: effects and treatment. J Clin Psychiatry. 2007;68 Suppl 14:8-13.
PubMed 18284272Fox 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.
PubMed 16341210Bogialli 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.
PubMed 12772270Rieger 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.
PubMed 19044213Barros 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.
PubMed 22070124
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01903915
- Acronym / sponsor ID
- 07052012
- Conditions
- Schizophrenia, Social Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Schizophrenia group |
| Control | – | –Healthy control group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients groups will be selected from psychiatric clinic in general hospital - Asan Medical Center.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- have Illness which can affect brain structures and functions
- can't be taken magnetic resonance imaging(MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Background: PubMed 17329470Garrity 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.
- Background: PubMed 11603801Hans 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.
- Background: PubMed 18985098Amodio 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.
- Background: PubMed 1389813Newton 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.
- Background: PubMed 18061989Klee 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.
- Background: PubMed 18057197Tan 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.
- Background: PubMed 18284272Keefe RS. Cognitive deficits in patients with schizophrenia: effects and treatment. J Clin Psychiatry. 2007;68 Suppl 14:8-13.
- Background: PubMed 16341210Fox 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.
- Background: PubMed 12772270Bogialli 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.
- Background: PubMed 19044213Rieger 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.
- Background: PubMed 22070124Barros 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Sun Lee, MD principal investigator
Department of Psychiatry, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Social Cognition, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Sun Lee, MD (82 2 3010 3422, js_lee@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of resting state functional MRI between schizophrenia patients and healthy controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01903915, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013; AzTrials last refreshed its copy on 30 Oct 2026.