Social Cognition of Schizophrenia, Bipolas or Depressed PatientsCOG-PSYCHONCT04928053
COG-PSYCHO : Social Cognition and Psychotic Characteristics: Genetic and Phenomic Approach
A study testing ocytocine dosage and genetic analyse in people with Social Cognition of Schizophrenia, Bipolas or Depressed Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Bipolar disorder (BD), schizophrenia and depression can feature cognitive impairment, especially in social cognition (SC). According to previous studies, some genes from the oxytocin and dopamine pathways may be involved SC performance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Social Cognition of Schizophrenia, Bipolas or Depressed Patients
- What is being tested?
- ocytocine dosage and genetic analyse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2019to Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy (urine test performed prior to inclusion in the program)
- "
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognition Sociale et caractéristiques Psychotiques : Approche génétique et phénomique
Bipolar disorder (BD), schizophrenia and depression can feature cognitive impairment, especially in social cognition (SC). According to previous studies, some genes from the oxytocin and dopamine pathways may be involved SC performance. Our endophenotype approach aimed to demonstrate that SC deficits are more severe in schizophrenia and BD or depression with psychotic symptoms (PBP) and are associated with certain Single Nucleotide Polymorphisms (SNPs) variants.
600 patients with schizophrenia, BD ou depression with and without psychotic symptoms will be recrited. Social Cognition was assessed using 4 paradigms: Reading the Mind in the Eyes Test (RMET), Interpersonal Reactivity Index (IRI), Empathy Quotient (QE), and a modified Delay Discounting task. After DNA extraction from blood or saliva sample, we used PCR amplification and real-time detection to genotype SNPs from Oxytocin pathways. he level of ocytocine will be also mesured.
Read the detailed description
Schizophrenia and mood disorders represent two severe and frequent disease with heterogeneous phenotype sharing some clinical symptoms (possible presence of psychotic symptoms in mood disorders, systematic in schizophrenia) and neurocognitive impairments including social cognition. These disorders result from an interaction of several minor effect genes with various early or late environmental factors, with psychosocial or biological origin.
The association of these pathologies with dysfunctions of major neurotransmission systems has been the subject of numerous studies, but the results have often been contradictory for methodological, clinical (phenotypic heterogeneity) and finally genetic reasons. The definition of the phenotype is an essential issue in research on the genetics of mental disorders. The risk of phenotypic misclassification of subjects during genetic studies confirms the need for a better delimitation of homogeneous patient sub-populations. The development by the National Institute of Mental Health (NIMH) of clinical research criteria is essential to bring sufficient power to modern research in genetics, but also in imaging, neuroscience or behavioral sciences of mental disorders.
The aim of our work is to study a restricted phenotype of schizophrenia and mood disorders: the assessment of social cognitions. Deficits in social cognition constitute one of the subconstructs described by the NIMH and lead to functional and clinical maladjustment hindering psychosocial rehabilitation. Indeed, oxytocin is reported to be a mediator of the regulation of social cognition (including empathy and theory of mind) and emotional behaviors (Meyer-Lindenberg, 2011).
The current project involves the analysis of several social cognition tasks that measure social perception, facial recognition of affect and empathy. The objective of this work is to highlight an association between performance on the 4 social cognition paradigms and polymorphisms of the OXT and OXTR genes and in a population of subjects suffering from schizophrenia or mood disorder with or without psychotic symptoms.
The main hypothesis of this study is that these genes have an impact on social cognition in each of the populations recruited (patients with schizophrenia or patients with a mood disorder). The secondary hypothesis is to show that this impact of the genotype is more marked in patients with psychotic symptoms (suffering from mood disorders or schizophrenia) compared to patients suffering from mood disorders without psychotic symptoms (interaction mechanism).
Main objective : To show the association between variants of the OXT and OXTR genes and the deficit in social cognition observed in patients with schizophrenia or a mood disorder with or without psychotic features.
Primary endpoint : Performance on the Reading the Mind in the Eyes Test (RMET), which measures the ability to attribute emotions to others.
Secondary Objectives :
- To show the impact of the OXT and OXTR genes on 3 other paradigms of social cognition, and in the following subgroups: schizophrenic patients, patients with mood disorders, patients with psychotic symptoms and patients without psychotic symptoms.
- To highlight interactions between genetic variants of the OXT and OXTR genes with the main impaired cognitive and neurological capacities in schizophrenia and mood disorders (attention, executive and memory function).
- To search for an association between traumatic life events in childhood and delusional clinical phenotype and impaired cognition in mood disorders.
- To demonstrate that plasma oxytocin levels are decreased in patients with psychotic symptoms compared to patients without psychotic symptoms and correlated with social cognition performance in the total sample of subjects as well as in each of these subgroups.
- To demonstrate that OXTR gene expression is reduced in patients with psychotic symptoms (schizophrenia or mood disorder with psychotic symptoms) compared to subjects without psychotic symptoms (mood disorder without psychotic symptoms), and correlated with social cognitive performance in the total sample of subjects and in each of these subgroups.
Secondary Evaluation Criteria :
- Performance on three other tests measuring social cognitions: Delay Discouting applied to social cognitions, Interpersonal Reactivity Index and Empathy Quotient (Berthoz et al., 2008)
- RMET test performance
- Potentially traumatic life events (CTQ questionnaire)
- Plasma determination of circulating oxytocin
- mRNA expression level of the OXTR gene measured by RT-qPCR Monocentric cross-sectional study evaluating social cognition in patients suffering from schizophrenia, mood disorder with or without psychotic symptoms in search of genetic determinants involved in social cognition performance.
Patients undergo biological sampling (genotyping of variants of the OXT and OXTR genes, quantification of circulating oxytocin and quantification of OXTR transcript expression) and undergo several evaluations (RMET, Delay Discounting, Interpersonal Reactivity Index, Empathy Quotient).
Criteria for inclusion
- Major patient under 75 years of age
- Presenting the DSM-5 criteria for schizophrenia, bipolar disorder or major depressive episode.
- Capable of giving consent or under curatorship
- Benefiting from a health insurance plan Criteria for non-inclusion Pregnancy (urine test performed prior to inclusion in the program) Procedure A single three-hour face-to-face interview will be carried out at the inclusion, in an inpatient or outpatient setting. Patients will have a 30-minute social cognition assessment by the RMET, two empathy self-questionnaires: IRI and QE, and a computerized update time stamp.
The collection of standardized psychiatric and addictological diagnoses using the DIGS is under the responsibility of Professor DUBERTRET (Hôpital Louis Mourier) in order to define the groups of subjects. There is no follow-up on a day-by-day basis; patient participation is one day.
All subjects will have a blood sample in order to perform genetic analyses including genotyping of the genes tested, quantification of OXTR mRNA expressed in peripheral venous blood (biogps) by RT-qPCR and oxytocin assay.
Number of patients 600 patients
1 (monocentric study) Duration of inclusion: 5 years Duration of participation (treatment + follow-up):1 day Total research duration 5 years
- Being tested
- ocytocine dosage and genetic analyse
- Keywords
- social cognition of schizophrenia, bipolas or depressed patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocytocine dosage and genetic analyseGenetic
All patients are assessed using 4 paradigms: Reading the Mind in the Eyes Test (RMET), Interpersonal Reactivity Index (IRI), Empathy Quotient (QE), and a modified Delay Discounting task. They have a blood prelevment
| Study group | Role | What they receive |
|---|---|---|
| phenotypic data and a blood prelevment | Experimental | Not described Receives: Genetic: ocytocine dosage and genetic analyse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Showing an correlation between SNPs of OXT et OXTR genes and social performence observed in patients with schizophrenia and bipolar or depressed patients with or without psychotic characteristics.
performence at RMET (Reading the Mind in the Eyes Test)
Measured: 5 years
Secondary outcomes (7)
Interpersonal Reactivity Index (IRI)
Impact of OXT, OXTR genes and social performence emesured with Interpersonal Reactivity Index (IRI) observed in patients with schizophrenia and bipolar or depressed patients with or without psychotic characteristics.
Measured: 5 years
Empathy Quotient (QE)
Impact of OXT, OXTR genes and social performence emesured with Empathy Quotient (QE) observed in patients with schizophrenia and bipolar or depressed patients with or without psychotic characteristics.
Measured: 5 years
modified Delay Discounting task
Impact of OXT, OXTR genes and social performence emesured with a modified Delay Discounting task observed in patients with schizophrenia and bipolar or depressed patients with or without psychotic characteristics.
Measured: 5 years
Cognitive performence
correlation between SNPs of OXT et OXTR genes and general cognition scores (attention, executive and mnesisic fonction)
Measured: 5 years
Potentially traumatic life events (CTQ questionnaire)
Association between traumatic events and psychotic characteristics and cognition scores
Measured: 5 years
Plasma determination of circulating oxytocin
- Plasma determination of oxytocin in patients with schizophrenia and bipolar, depressed patients and those without psychotic characteristics
Measured: 5 years
mRNA expression level of the OXTR gene measured by RT-qPCR
Expression of OXT et OXTR genes reduced and associated with social performence observed in patients with schizophrenia and bipolar or depressed patients with psychotic characteristics compared with those without
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start4 Feb 2019
- Primary completion4 Feb 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Cognition of Schizophrenia, Bipolas or Depressed PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Dubertret, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928053
- Sponsor's protocol ID
- N°IDRCB 2018-A1459-46
- Acronym
- COG-PSYCHO
- Status last verified
- Oct 2022
- First submitted
- 26 Feb 2021
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition Sociale et caractéristiques Psychotiques : Approche génétique et phénomique
- ClinicalTrials.gov ID
- NCT04928053
- Acronym / sponsor ID
- COG-PSYCHO / N°IDRCB 2018-A1459-46
- Keywords
- social cognition of schizophrenia, bipolas or depressed patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 4 Feb 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Jun 2021 (actual)
- 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.
Bipolar disorder (BD), schizophrenia and depression can feature cognitive impairment, especially in social cognition (SC). According to previous studies, some genes from the oxytocin and dopamine pathways may be involved SC performance. Our endophenotype approach aimed to demonstrate that SC deficits are more severe in schizophrenia and BD or depression with psychotic symptoms (PBP) and are associated with certain Single Nucleotide Polymorphisms (SNPs) variants.
600 patients with schizophrenia, BD ou depression with and without psychotic symptoms will be recrited. Social Cognition was assessed using 4 paradigms: Reading the Mind in the Eyes Test (RMET), Interpersonal Reactivity Index (IRI), Empathy Quotient (QE), and a modified Delay Discounting task. After DNA extraction from blood or saliva sample, we used PCR amplification and real-time detection to genotype SNPs from Oxytocin pathways. he level of ocytocine will be also mesured.
Detailed description
Schizophrenia and mood disorders represent two severe and frequent disease with heterogeneous phenotype sharing some clinical symptoms (possible presence of psychotic symptoms in mood disorders, systematic in schizophrenia) and neurocognitive impairments including social cognition. These disorders result from an interaction of several minor effect genes with various early or late environmental factors, with psychosocial or biological origin.
The association of these pathologies with dysfunctions of major neurotransmission systems has been the subject of numerous studies, but the results have often been contradictory for methodological, clinical (phenotypic heterogeneity) and finally genetic reasons. The definition of the phenotype is an essential issue in research on the genetics of mental disorders. The risk of phenotypic misclassification of subjects during genetic studies confirms the need for a better delimitation of homogeneous patient sub-populations. The development by the National Institute of Mental Health (NIMH) of clinical research criteria is essential to bring sufficient power to modern research in genetics, but also in imaging, neuroscience or behavioral sciences of mental disorders.
The aim of our work is to study a restricted phenotype of schizophrenia and mood disorders: the assessment of social cognitions. Deficits in social cognition constitute one of the subconstructs described by the NIMH and lead to functional and clinical maladjustment hindering psychosocial rehabilitation. Indeed, oxytocin is reported to be a mediator of the regulation of social cognition (including empathy and theory of mind) and emotional behaviors (Meyer-Lindenberg, 2011).
The current project involves the analysis of several social cognition tasks that measure social perception, facial recognition of affect and empathy. The objective of this work is to highlight an association between performance on the 4 social cognition paradigms and polymorphisms of the OXT and OXTR genes and in a population of subjects suffering from schizophrenia or mood disorder with or without psychotic symptoms.
The main hypothesis of this study is that these genes have an impact on social cognition in each of the populations recruited (patients with schizophrenia or patients with a mood disorder). The secondary hypothesis is to show that this impact of the genotype is more marked in patients with psychotic symptoms (suffering from mood disorders or schizophrenia) compared to patients suffering from mood disorders without psychotic symptoms (interaction mechanism).
Main objective : To show the association between variants of the OXT and OXTR genes and the deficit in social cognition observed in patients with schizophrenia or a mood disorder with or without psychotic features.
Primary endpoint : Performance on the Reading the Mind in the Eyes Test (RMET), which measures the ability to attribute emotions to others.
Secondary Objectives :
- To show the impact of the OXT and OXTR genes on 3 other paradigms of social cognition, and in the following subgroups: schizophrenic patients, patients with mood disorders, patients with psychotic symptoms and patients without psychotic symptoms.
- To highlight interactions between genetic variants of the OXT and OXTR genes with the main impaired cognitive and neurological capacities in schizophrenia and mood disorders (attention, executive and memory function).
- To search for an association between traumatic life events in childhood and delusional clinical phenotype and impaired cognition in mood disorders.
- To demonstrate that plasma oxytocin levels are decreased in patients with psychotic symptoms compared to patients without psychotic symptoms and correlated with social cognition performance in the total sample of subjects as well as in each of these subgroups.
- To demonstrate that OXTR gene expression is reduced in patients with psychotic symptoms (schizophrenia or mood disorder with psychotic symptoms) compared to subjects without psychotic symptoms (mood disorder without psychotic symptoms), and correlated with social cognitive performance in the total sample of subjects and in each of these subgroups.
Secondary Evaluation Criteria :
- Performance on three other tests measuring social cognitions: Delay Discouting applied to social cognitions, Interpersonal Reactivity Index and Empathy Quotient (Berthoz et al., 2008)
- RMET test performance
- Potentially traumatic life events (CTQ questionnaire)
- Plasma determination of circulating oxytocin
- mRNA expression level of the OXTR gene measured by RT-qPCR Monocentric cross-sectional study evaluating social cognition in patients suffering from schizophrenia, mood disorder with or without psychotic symptoms in search of genetic determinants involved in social cognition performance.
Patients undergo biological sampling (genotyping of variants of the OXT and OXTR genes, quantification of circulating oxytocin and quantification of OXTR transcript expression) and undergo several evaluations (RMET, Delay Discounting, Interpersonal Reactivity Index, Empathy Quotient).
Criteria for inclusion
- Major patient under 75 years of age
- Presenting the DSM-5 criteria for schizophrenia, bipolar disorder or major depressive episode.
- Capable of giving consent or under curatorship
- Benefiting from a health insurance plan Criteria for non-inclusion Pregnancy (urine test performed prior to inclusion in the program) Procedure A single three-hour face-to-face interview will be carried out at the inclusion, in an inpatient or outpatient setting. Patients will have a 30-minute social cognition assessment by the RMET, two empathy self-questionnaires: IRI and QE, and a computerized update time stamp.
The collection of standardized psychiatric and addictological diagnoses using the DIGS is under the responsibility of Professor DUBERTRET (Hôpital Louis Mourier) in order to define the groups of subjects. There is no follow-up on a day-by-day basis; patient participation is one day.
All subjects will have a blood sample in order to perform genetic analyses including genotyping of the genes tested, quantification of OXTR mRNA expressed in peripheral venous blood (biogps) by RT-qPCR and oxytocin assay.
Number of patients 600 patients
1 (monocentric study) Duration of inclusion: 5 years Duration of participation (treatment + follow-up):1 day Total research duration 5 years
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| phenotypic data and a blood prelevment | Experimental | Genetic: ocytocine dosage and genetic analyse |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Pregnancy (urine test performed prior to inclusion in the program)
- "
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 |
|---|---|---|
| ocytocine dosage and genetic analyseAll patients are assessed using 4 paradigms: Reading the Mind in the Eyes Test (RMET), Interpersonal Reactivity Index (IRI), Empathy Quotient (QE), and a modified Delay Discounting task. They have a blood prelevment | Genetic | phenotypic data and a blood prelevment |
Primary outcome
Showing an correlation between SNPs of OXT et OXTR genes and social performence observed in patients with schizophrenia and bipolar or depressed patients with or without psychotic characteristics.
Time frame: 5 years
performence at RMET (Reading the Mind in the Eyes Test)
7 secondary outcomes
Interpersonal Reactivity Index (IRI)
Time frame: 5 years
Empathy Quotient (QE)
Time frame: 5 years
modified Delay Discounting task
Time frame: 5 years
Cognitive performence
Time frame: 5 years
Potentially traumatic life events (CTQ questionnaire)
Time frame: 5 years
Plasma determination of circulating oxytocin
Time frame: 5 years
mRNA expression level of the OXTR gene measured by RT-qPCR
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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.
Caroline Dubertret principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ocytocine dosage and genetic analyse in people with Social Cognition of Schizophrenia, Bipolas or Depressed Patients, run by Assistance Publique - Hôpitaux de Paris 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 0 inclusion and 2 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 31 Oct 2022. 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 Caroline Dubertret, MD, PhD (33147606409, caroline.dubertret@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Showing an correlation between SNPs of OXT et OXTR genes and social performence observed in patients with schizophrenia and bipolar or depressed patients with or without psychotic characteristics. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2022.