Clinical trial NCT02110017: Exploration of Neural Bases in Social Cognition
Official title: Exploration of Neural Bases in Social Cognition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interpersonal Relations
Schizophrenia
Magnetic Resonance Imaging, Functional
Keywords: Ecological task
fMRI
Schizophrenia
Social Cognition
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* pregnant woman
* neurological affection
* medical objection to Magnetic Resonance Imagery (MRI)

Primary outcomes:
measure: Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal
timeFrame: Day 1 for individual analysis. Up to 24 months for group analysis.
Secondary outcomes:
measure: Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
timeFrame: Day 1 for individual analysis. Up to 24 months for group analysis.
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Hospitalier Universitaire
state: Normandy
Study officials:
affiliation: 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
name: Perrine BRAZO, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: