SchizophreniaSCHIZOIMAGENNCT02834208
Emotion Endophenotypes in Schizophrenia
A study testing MRI (Magnetic resonance imaging), Polymorphism (SNP in DNA) and quantitative measures of mRNA in people with Schizophrenia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MRI (Magnetic resonance imaging), Polymorphism (SNP in DNA) and quantitative measures of mRNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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…)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pôle Psychiatrie Centre CHU Conception, Marseille, APHM
Marseille, 13005
Xavier ZENDJIDJIAN, Dr, 04.91.43.50.47 ext. +33, xavier.zendjidjian@ap-hm.fr
About this study
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
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
- Being tested
- MRI (Magnetic resonance imaging), Polymorphism (SNP in DNA), quantitative measures of mRNA, Neuropsychological assessment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI (Magnetic resonance imaging)Other
Polymorphism (SNP in DNA)Genetic
quantitative measures of mRNAGenetic
Neuropsychological assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia subjects | Experimental | 35 patients suffering from schizophrenia Receives: 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 Receives: 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 Receives: Other: MRI (Magnetic resonance imaging); Genetic: Polymorphism (SNP in DNA); Genetic: quantitative measures of mRNA; Other: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI
Measured: 4 hours
Secondary outcomes (4)
Assessment of the functional connectivity in cortico-limbic circuit which underlie the emotional information using functional MRI
Measured: 4 hours
Description of whole brain neuro-anatomy based using Voxel Brain Morphometry (VBM)
Measured: 4 hours
Quantitative expression of messenger Ribo Nucleic Acid (mRNA) in Peripheral Blood Mononuclear Cells (PBMC)
Measured: 4 hours
Polymorphism (single-nucleotide polymorphism SNP) of DNA (DeoxyriboNucleic Acid)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834208
- Sponsor's protocol ID
- 2015-38
- Other IDs
- 2015-A01475-44
- Acronym
- SCHIZOIMAGEN
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41708484
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02834208
- Acronym / sponsor ID
- SCHIZOIMAGEN / 2015-38
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia subjects | Experimental | Other: MRI (Magnetic resonance imaging), Genetic: Polymorphism (SNP in DNA), Genetic: quantitative measures of mRNA, Other: Neuropsychological assessment35 patients suffering from schizophrenia |
| Healthy siblings | Other | Other: 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 controls | Other | Other: MRI (Magnetic resonance imaging), Genetic: Polymorphism (SNP in DNA), Genetic: quantitative measures of mRNA, Other: Neuropsychological assessment35 healthy "controls "patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI
Time frame: 4 hours
4 secondary outcomes
Assessment of the functional connectivity in cortico-limbic circuit which underlie the emotional information using functional MRI
Time frame: 4 hours
Description of whole brain neuro-anatomy based using Voxel Brain Morphometry (VBM)
Time frame: 4 hours
Quantitative expression of messenger Ribo Nucleic Acid (mRNA) in Peripheral Blood Mononuclear Cells (PBMC)
Time frame: 4 hours
Polymorphism (single-nucleotide polymorphism SNP) of DNA (DeoxyriboNucleic Acid)
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Derived from this study: PubMed 41708484Fiorito 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine GEINDRE study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI (Magnetic resonance imaging), Polymorphism (SNP in DNA) and quantitative measures of mRNA in people with Schizophrenia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier ZENDJIDJIAN, Dr (04.91.43.50.47 ext. +33, xavier.zendjidjian@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02834208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.