Exploration of Neural Bases in Social Cognition

Schizophrenia Clinical Trial

— IRM-COG  

Official title:

Exploration of Neural Bases in Social Cognition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02110017
• Other study ID #: RCB 2013-A00064-41
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2013
• Last updated: February 4, 2015
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

Description:

Social cognition neural basis. Impairment of the "social brain" in schizophrenia

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Interpersonal Relations
• Magnetic Resonance Imaging, Functional
• Schizophrenia

Intervention

Other:
• fMRI social cognition task
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 1 for individual analysis. Up to 24 months for group analysis.	No
Secondary	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.	Day 1 for individual analysis. Up to 24 months for group analysis.	No