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In people with schizophrenia or people with autism, impairments of social cognition are a core feature of the disease and, according to researchers who represent valuable references on this subject for the international community, three to five processes of social cognition are usually altered in those diseases: (1) emotional processing which is the ability to identify emotions through facial expressions, gestures, and tone of voice, (2) theory of mind (ToM), which is defined as "the ability to attribute mental states (beliefs, intents, desires, …) to oneself and others, and to understand that others have beliefs, intentions, and desires that are different from one's own", (3) attributional style which refers to how people explain the causes of positive and negative events, and corresponding, in schizophrenia, to self-serving and personalizing bias that means a tendency to blame others for negative life events rather than sharing the responsibilities between different sources; and (4 and 5) social perception and knowledge, which can be defined as decoding and interpreting social cues from others, taking the social context into account, and knowing social rules, roles, and goals. Components of social cognition appear to be related to both symptomatology and functioning in everyday life. The present study aims to assess a new social cognitive battery developed by several teams in France: ClaCoS.
The project's objectives are: (1) to assess relevance of ClaCoS in schizophrenia and autism compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery.
For the first objective, three kind of evaluation will be proposed: clinical, neurocognitive and social cognitive (ClaCoS). Three populations of 80 participants will be compared: healthy controls, patients with schizophrenia or schizoaffective disorders, and patients with autism spectrum disorders. These three groups will be matched on sex, age and level of education.
For the second objective a systematic collection of data will be carried out in a large sample of healthy controls. In this part of the study, only social cognitive measures will be recorded. Subjects will be ranked according to three criteria: three classes for age (18-25 years old, 26-35 and 36-45), five classes for socio-professional status according to the INSEE classification, and two classes for sex (men/women).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| schizophrenia | Experimental | this project is to assess relevance of ClaCoS in schizophrenia compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery. |
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| autism | Experimental | this project is to assess relevance of ClaCoS in autism compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery. |
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| healthy controls | Placebo Comparator | this project is to assess relevance of ClaCoS in autism compared to healthy controls, and to analyze links between social cognition and both neurocognition and symptoms, (2) to collect data in a large sample of healthy controls in order to establish appropriate standards for tools composing ClaCoS battery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| schizophrenia | Behavioral | The battery (ClaCoS) is composed by 6 tests and several scores will be recorded for each:
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in social cognition measures | The battery (ClaCoS ) is composed by 6 tests and several scores will be recorded for each:
| Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in symptoms measure | Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS) | Week 12 |
| Change from Baseline in Neurocognitive functioning measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FRANCK NICOLAS, PUPH | Service Universitaire de Réhabilitation - Le Vinatier Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professeur FRANCK Nicolas | Bron | Auvergne-Rhône-Alpes | 69678 | France |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Autism | Behavioral | The battery (ClaCoS ) is composed by 6 tests and several scores will be recorded for each:
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| Healthy controls | Behavioral | only social cognitive measures |
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Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.
| Week 12 |