Interpersonal RelationsIRM-COGNCT02110017
Exploration of Neural Bases in Social Cognition
A study testing fMRI social cognition task in people with Interpersonal Relations and Schizophrenia, run by University Hospital, Caen at 1 site in France.
Trial summary
An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Interpersonal Relations, Schizophrenia, Magnetic Resonance Imaging, Functional
- What is being tested?
- fMRI social cognition task
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Sep 2015
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged from 18 to 60 years old
- who have signed a consent and, if there is one, whose legal representant has signed a consent
- 1)For healthy subjects:
- without any psychiatric affection (Mini International Neuropsychiatric Interview)
- 2)For patients
- meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder
Who cannot join
- pregnant woman
- neurological affection
- medical objection to Magnetic Resonance Imagery (MRI)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire
Caen, Normandy, 14000
Perrine Brazo, MD-PhD, 0033231065018
Vincent B Marzloff, MD, 0033231064424, marzloff-v@chu-caen.fr
About this study
An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. It includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (ToM), social perception, social knowledge and attributional style. Since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the main objective of this study. The secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).
Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to test the secondary objective. We make the hypothesis of a fMRI functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.
Read the detailed description
Social cognition neural basis. Impairment of the "social brain" in schizophrenia
- Being tested
- fMRI social cognition task
- Keywords
- Ecological task, fMRI, 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.
fMRI social cognition taskOther
Also called Philips 3 Tesla fMRI
fMRI social cognition task : each subject will go through 3 runs of a fMRI paradigm, first one verbal then two visual runs, which are meant to activate the theory of mind network.
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Other | Twenty patients suffering from schizophrenia (DSM-IV-R), with medication and medical care. No recent relapse of the psychotic disease, nor change in medications.
No neurological comorbidity.
After anatomic scans, each subject will go through the fMRI social cognition task. Receives: Other: fMRI social cognition task |
| Healthy subjects | Other | Twenty healthy subjects (no mental or neurological disease)
After anatomic scans, each subject will go through the fMRI social cognition task. Receives: Other: fMRI social cognition task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal
The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05)
Measured: Day 1 for individual analysis. Up to 24 months for group analysis.
Secondary outcomes (1)
Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Using the previous social cognition ecological task, BOLD signal variations at a high statistical correction ratio (p<0.05) of 20 patients with schizophrenia will be compared to those of 20 matched healthy subjects.
Measured: Day 1 for individual analysis. Up to 24 months for group analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interpersonal RelationsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine BRAZO, MD-PhD, Principal investigator, University of Caen, UMR 6301 ISTCT ISTS group; CNRS UMR 6301 ISTCT GIP Cyceron; CEA UMR 6301 ISTCT; CHU de Caen, Department of psychiatry, Centre Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110017
- Sponsor's protocol ID
- RCB 2013-A00064-41
- Acronym
- IRM-COG
- Status last verified
- Feb 2015
- First submitted
- 12 Sep 2013
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Neural Bases in Social Cognition
- ClinicalTrials.gov ID
- NCT02110017
- Acronym / sponsor ID
- IRM-COG / RCB 2013-A00064-41
- Keywords
- Ecological task, fMRI, Schizophrenia, Social Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 10 Apr 2014 (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.
An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. It includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (ToM), social perception, social knowledge and attributional style. Since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the main objective of this study. The secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).
Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to test the secondary objective. We make the hypothesis of a fMRI functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.
Detailed description
Social cognition neural basis. Impairment of the "social brain" in schizophrenia
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Other | Other: fMRI social cognition taskTwenty patients suffering from schizophrenia (DSM-IV-R), with medication and medical care. No recent relapse of the psychotic disease, nor change in medications. No neurological comorbidity. After anatomic scans, each subject will go through the fMRI social cognition task. |
| Healthy subjects | Other | Other: fMRI social cognition taskTwenty healthy subjects (no mental or neurological disease) After anatomic scans, each subject will go through the fMRI social cognition task. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects aged from 18 to 60 years old
- who have signed a consent and, if there is one, whose legal representant has signed a consent
- without any psychiatric affection (Mini International Neuropsychiatric Interview)
- 2)For patients
- meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder
Key exclusion criteria (3 listed)
- pregnant woman
- neurological affection
- medical objection to Magnetic Resonance Imagery (MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI social cognition taskAlso: Philips 3 Tesla fMRIfMRI social cognition task : each subject will go through 3 runs of a fMRI paradigm, first one verbal then two visual runs, which are meant to activate the theory of mind network. | Other | Healthy subjects, Patients with schizophrenia |
Primary outcome
Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal
Time frame: Day 1 for individual analysis. Up to 24 months for group analysis.
The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05)
1 secondary outcome
Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Time frame: Day 1 for individual analysis. Up to 24 months for group analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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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.
Perrine BRAZO, MD-PhD principal investigator
University of Caen, UMR 6301 ISTCT ISTS group; CNRS UMR 6301 ISTCT GIP Cyceron; CEA UMR 6301 ISTCT; CHU de Caen, Department of psychiatry, Centre Esquirol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI social cognition task in people with Interpersonal Relations and Schizophrenia, run by University Hospital, Caen at 1 site in France.
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 6 inclusion and 3 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 5 Feb 2015. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal (time frame: Day 1 for individual analysis. Up to 24 months for group analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2015.