Emotion Endophenotypes in Schizophrenia

Not Applicable

• Conditions: Schizophrenia
• Interventions: Other: MRI (Magnetic resonance imaging); Genetic: Polymorphism (SNP in DNA); Genetic: quantitative measures of mRNA; Other: Neuropsychological assessment

• Registration Number: NCT02834208
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-15
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Schizophrenia subjects	Polymorphism (SNP in DNA)	35 patients suffering from schizophrenia
Schizophrenia subjects	Neuropsychological assessment	35 patients suffering from schizophrenia
Healthy siblings	Polymorphism (SNP in DNA)	35 healthy siblings of the patients suffering from schizophrenia
Schizophrenia subjects	quantitative measures of mRNA	35 patients suffering from schizophrenia
Schizophrenia subjects	MRI (Magnetic resonance imaging)	35 patients suffering from schizophrenia
Healthy siblings	MRI (Magnetic resonance imaging)	35 healthy siblings of the patients suffering from schizophrenia
Healthy controls	Neuropsychological assessment	35 healthy "controls "patients
Healthy controls	quantitative measures of mRNA	35 healthy "controls "patients
Healthy siblings	quantitative measures of mRNA	35 healthy siblings of the patients suffering from schizophrenia
Healthy controls	MRI (Magnetic resonance imaging)	35 healthy "controls "patients
Healthy siblings	Neuropsychological assessment	35 healthy siblings of the patients suffering from schizophrenia
Healthy controls	Polymorphism (SNP in DNA)	35 healthy "controls "patients

Primary Outcome Measures

Name	Time	Method
Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI	4 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pôle Psychiatrie Centre CHU Conception, Marseille, APHM; 🇫🇷 Marseille, France