Emotion Endophenotypes in Schizophrenia

NCT02834208 | Unknown

• 2 other identifiers: 2015-382015-A01475-44
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI

  4 hours

Secondary Outcomes (4)

• 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

Study Arms (3)

Schizophrenia subjects

EXPERIMENTAL

35 patients suffering from schizophrenia

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

Healthy siblings

OTHER

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

Healthy controls

OTHER

35 healthy "controls "patients

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

Interventions

MRI (Magnetic resonance imaging) OTHER

Healthy controls; Healthy siblings; Schizophrenia subjects

Polymorphism (SNP in DNA) GENETIC

Healthy controls; Healthy siblings; Schizophrenia subjects

quantitative measures of mRNA GENETIC

Healthy controls; Healthy siblings; Schizophrenia subjects

Neuropsychological assessment OTHER

Healthy controls; Healthy siblings; Schizophrenia subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Contraindication to an MRI test (metallic foreign body, pacemaker, heart valve, chirurgical clip, claustrophobia…)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Pôle Psychiatrie Centre CHU Conception, Marseille, APHM

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Magnetic Resonance Spectroscopy; Polymorphism, Genetic; Polymorphism, Single Nucleotide; DNA; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Genetic Variation; Genetic Phenomena; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Catherine GEINDRE

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Xavier ZENDJIDJIAN, Dr

CONTACT

04.91.43.50.47; xavier.zendjidjian@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 15, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 30, 2016

Record last verified: 2016-07

Locations

FR (1)