Schizophrenia Clinical Trial
— (ClaCoS)Official title:
Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS
Verified date | January 2022 |
Source | Hôpital le Vinatier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 440 |
Est. completion date | June 30, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Aged 18-45 years old - No psychiatric or neurologic conditions or comorbidity - No relatives with people with people with history of neuropsychiatric disease - French native language or education in a French school since the first year of primary school - Consent to participate to the study Exclusion Criteria: - Aged 18-45 years old - Patients with schizophrenia: diagnosis assessed with DSM5 criteria - No modification of psychotropic treatment during the month before inclusion - French native language or education in a French school since the first year of primary school - Consent to participate to the study and agreement of the legal guardian |
Country | Name | City | State |
---|---|---|---|
France | Professeur FRANCK Nicolas | Bron | Rhone-alpes |
Lead Sponsor | Collaborator |
---|---|
Hôpital le Vinatier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ) |
Week 12 | |
Secondary | 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 | |
Secondary | Change from Baseline in Neurocognitive functioning measures | Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed. | Week 12 |
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