Clinical trial NCT02660775: Social Cognitive Assessment in Autism and Schizophrenia
Official title: Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in social cognition measures
timeFrame: Week 12
Secondary outcomes:
measure: Change from Baseline in symptoms measure
timeFrame: Week 12
measure: Change from Baseline in Neurocognitive functioning measures
timeFrame: Week 12
Other outcomes:
Locations:
city: Bron
country: France
facility: Professeur FRANCK Nicolas
state: Rhone-alpes
Study officials:
affiliation: Service Universitaire de Réhabilitation - Le Vinatier Hospital
name: FRANCK NICOLAS, PUPH
role: PRINCIPAL_INVESTIGATOR
References: