Emotion Endophenotypes in Schizophrenia

Schizophrenia Clinical Trial

— SCHIZOIMAGEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02834208
• Other study ID #: 2015-38
• Secondary ID: 2015-A01475-44
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2016
• Last updated: August 29, 2016
• Start date: December 2015
• Est. completion date: June 2019

Study information

• Verified date: July 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Xavier ZENDJIDJIAN, Dr
• Phone: 04.91.43.50.47
• Email: xavier.zendjidjian[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• MRI (Magnetic resonance imaging)

Genetic:
• Polymorphism (SNP in DNA)

• quantitative measures of mRNA

Other:
• Neuropsychological assessment

Locations

Country	Name	City	State
France	Pôle Psychiatrie Centre CHU Conception, Marseille, APHM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI		4 hours	No
Secondary	Assessment of the functional connectivity in cortico-limbic circuit which underlie the emotional information using functional MRI		4 hours	No
Secondary	Description of whole brain neuro-anatomy based using Voxel Brain Morphometry (VBM)		4 hours	No
Secondary	Quantitative expression of messenger Ribo Nucleic Acid (mRNA) in Peripheral Blood Mononuclear Cells (PBMC)		4 hours	No
Secondary	Polymorphism (single-nucleotide polymorphism SNP) of DNA (DeoxyriboNucleic Acid)		4 hours	No