Emotion Endophenotypes in Schizophrenia (SCHIZOIMAGEN)

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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Other: MRI (Magnetic resonance imaging); Genetic: Polymorphism (SNP in DNA); Genetic: quantitative measures of mRNA; Other: Neuropsychological assessment

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Pôle Psychiatrie Centre CHU Conception, Marseille, APHM
    • Contact: Xavier ZENDJIDJIAN, Dr; Phone Number: +33 04.91.43.50.47; Email: xavier.zendjidjian@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2015-38; 2015-A01475-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided