An interventional study of schizophrenia and Autism in Schizophrenia, sponsored by Hôpital le Vinatier. Completed at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Screening
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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Exclusion Criteria:
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.
Behavioral: schizophrenia
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.
Behavioral: Autism
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.
Behavioral: Healthy controls
The battery (ClaCoS) is composed by 6 tests and several scores will be recorded for each: * for emotion perception : Facial emotions recognition task (TREF) * for theory of mind : Movie for the assessment of social cognition ( MASC-VF) * for attributional bias : Ambiguous Intentions Hostility Questionnaire ( AIHQ) * for social perception and knowledge : interpretation score - with and without index, comprehension score ( PerSo ) * for empathy :Questionnaire of cognitive and affective empathy ( QCAE) for people with schizophrenia * for self assessment : Self - assessment of social cognition (ACSo)
The battery (ClaCoS ) is composed by 6 tests and several scores will be recorded for each: * for emotion perception : Facial emotions recognition task(TREF ): total score, score per emotion, detection levels * for theory of mind : Movie for the assessment of social cognition (MASC ) :total score, error type * for attributional bias : Ambiguous Intentions Hostility Questionnaire (AIHQ) :hostility score, attribution score, aggression score * for social perception and knowledge : interpretation score - with and without index, comprehension score ( PerSo ) * for empathy : Empathy quotient (EQ) * for self assessment : Self - assessment of social cognition ( ACSo ): total score and scores per processes
only social cognitive measures
Change from Baseline in social cognition measures
The battery (ClaCoS ) is composed by 6 tests and several scores will be recorded for each: * for emotion perception : total score, score per emotion, detection levels (TREF) * for theory of mind : total score, error type (MASC) * for attributional bias : hostility score, attribution score, aggression score (AIHQ ) * for social perception and knowledge : interpretation score - with and without index, comprehension score (PerSo) * for empathy : Empathy quotient (EQ) for people with autism / Questionnaire of cognitive and affective empathy (QCAE )for people with schizophrenia (total score and sub scores) * for self assessment : total score and scores per processes( ACSo )
Time frame: Week 12
Change from Baseline in symptoms measure
Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS)
Time frame: Week 12
Change from Baseline in Neurocognitive functioning measures
Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.
Time frame: Week 12
Plan to share: No
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