Emotion Endophenotypes in Schizophrenia

NCT02834208 — Not applicable, Unknown, 105 participants, Assistance Publique Hopitaux De Marseille

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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

RegistryNCT02834208, acronym SCHIZOIMAGEN
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none
Enrollment105 (Estimated)
SponsorAssistance Publique Hopitaux De Marseille (Other)
ConditionsSchizophrenia
InterventionsMRI (Magnetic resonance imaging), Polymorphism (SNP in DNA), quantitative measures of mRNA, Neuropsychological assessment (Other, genetic)
Datesstart 2015-12-01, primary completion 2018-12-01 (estimated), completion 2019-06-01 (estimated), first posted 2016-07-15, last updated 2016-08-30
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Schizophrenia All trials of MRI (Magnetic resonance imaging) All trials of Polymorphism (SNP in DNA)

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Schizophrenia subjectsExperimentalOther: MRI (Magnetic resonance imaging); Genetic: Polymorphism (SNP in DNA); Genetic: quantitative measures of mRNA; Other: Neuropsychological assessment35 patients suffering from schizophrenia
Healthy siblingsOtherOther: MRI (Magnetic resonance imaging); Genetic: Polymorphism (SNP in DNA); Genetic: quantitative measures of mRNA; Other: Neuropsychological assessment35 healthy siblings of the patients suffering from schizophrenia
Healthy controlsOtherOther: MRI (Magnetic resonance imaging); Genetic: Polymorphism (SNP in DNA); Genetic: quantitative measures of mRNA; Other: Neuropsychological assessment35 healthy "controls "patients
  • MRI (Magnetic resonance imaging) (Other)
  • Polymorphism (SNP in DNA) (Genetic)
  • quantitative measures of mRNA (Genetic)
  • Neuropsychological assessment (Other)

+Outcome measures

Primary outcomes

  • Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI [4 hours]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 45 Years

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…)

+Locations (1)

FacilityCityCountryStatus
Pôle Psychiatrie Centre CHU Conception, Marseille, APHMMarseilleFranceRecruiting

+Publications

  • Results publication: Fiorito AM, Kheireddine A, Han H, Morel-Prieur C, Oriol N, Schneider FC, Sescousse G, Fakra E. Emotion Processing in Schizophrenia: Insights From a Brain Imaging Study Comparing Patients, Siblings, and Healthy Controls. Hum Brain Mapp. 2026 Feb 15;47(3):e70437. doi: 10.1002/hbm.70437. PMID 41708484

+Investigators

  • Catherine GEINDRE, Study director, Assistance Publique Hôpitaux de Marseille