Emotion Endophenotypes in Schizophrenia

Study Overview
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Brief Summary
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Schizophrenia is an invalidating psychiatric illness with a strong genetic component characterized by abnormal processing of emotional information. This alteration in emotion processing has been described in acute as well as in remission phases of the illness. It has also been found in healthy relatives of patients with schizophrenia and in subjects at high risk of psychosis. Thus, alterations in emotional information processing are not only linked to the prognosis but can also be considered as a marker of vulnerability of schizophrenia. In addition, schizophrenia patients differ from healthy controls in neural activity in brain regions implicated in emotions processing. However, interpretation of findings in patients is limited by confounding factors, such as antipsychotic treatments or alterations due to the course of illness. Also, there is no data concerning genetic factors (polymorphisms or gene expression) underlying these patterns of cerebral activation in emotion information processing. So, the main objective of this study is to compare the cerebral activity of schizophrenia patients to that of healthy siblings and healthy controls in an emotional processing task.

Official Title
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Neurofunctional Basis of Emotion Processing: Clinical, Genetic, Biological and Imaging Study in Patients With Schizophrenia and Healthy Relatives of Patients in Comparison With a Control Group

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: MRI (Magnetic resonance imaging)
* Genetic: Polymorphism (SNP in DNA)
* Genetic: quantitative measures of mRNA
* Other: Neuropsychological assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participant, right-handed, aged from 18 to 45 years old Haven given their written consent DSM-5 (Diagnostic and Statistical Manual of Mental Disorders version 5) diagnosis of schizophrenia Remitted phase (criteria of Andreasen) Stable doses of antipsychotics during the last 6 weeks No severe somatic illness Normal clinical exam Inscription to the social security Exclusion Criteria: Women in genitally active period without contraception Women pregnant or breast feeding Participants presenting a severe somatic /neurologic condition Present/history in the last year of alcohol or drug abuse Participating in another clinical study or still in period of exclusion of a previous clinical trial Contraindication to an MRI test (metallic foreign body, pacemaker, heart valve, chirurgical clip, claustrophobia…)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schizophrenia subjects<br>35 patients suffering from schizophrenia | Other: MRI (Magnetic resonance imaging)<br> <br> Genetic: Polymorphism (SNP in DNA)<br> <br> Genetic: quantitative measures of mRNA<br> <br> Other: Neuropsychological assessment<br> <br> |
| Other: Healthy siblings<br>35 healthy siblings of the patients suffering from schizophrenia | Other: MRI (Magnetic resonance imaging)<br> <br> Genetic: Polymorphism (SNP in DNA)<br> <br> Genetic: quantitative measures of mRNA<br> <br> Other: Neuropsychological assessment<br> <br> |
| Other: Healthy controls<br>35 healthy controls patients | Other: MRI (Magnetic resonance imaging)<br> <br> Genetic: Polymorphism (SNP in DNA)<br> <br> Genetic: quantitative measures of mRNA<br> <br> Other: Neuropsychological assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the functional connectivity in cortico-limbic circuit which underlie the emotional information using functional MRI |  | 4 hours | 
| Description of whole brain neuro-anatomy based using Voxel Brain Morphometry (VBM) |  | 4 hours | 
| Quantitative expression of messenger Ribo Nucleic Acid (mRNA) in Peripheral Blood Mononuclear Cells (PBMC) |  | 4 hours | 
| Polymorphism (single-nucleotide polymorphism SNP) of DNA (DeoxyriboNucleic Acid) |  | 4 hours |