Schizophrenia(ClaCoS)NCT02660775
Social Cognitive Assessment in Autism and Schizophrenia
A study testing schizophrenia and Autism in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- schizophrenia and Autism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2015to 30 Jun 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS
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.
Read the 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).
- Conditions
- Schizophrenia
- Being tested
- schizophrenia, Autism, Healthy controls
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
schizophreniaBehavioural
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)
AutismBehavioural
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
Healthy controlsBehavioural
only social cognitive measures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: schizophrenia |
| 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. Receives: Behavioral: Autism |
| 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. Receives: Behavioral: Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: Week 12
Secondary outcomes (2)
Change from Baseline in symptoms measure
Positive and negative symptoms scale, global score, positive sub scale score and negative sub scale score (PANSS)
Measured: Week 12
Change from Baseline in Neurocognitive functioning measures
Several neurocognitive processes will be assessed and notably memory, attention, executive functions, and processing speed.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start4 Dec 2015
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCK NICOLAS, PUPH, Principal investigator, Service Universitaire de Réhabilitation - Le Vinatier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660775
- Sponsor's protocol ID
- 2015-A00580-49
- Acronym
- (ClaCoS)
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2015
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS
- ClinicalTrials.gov ID
- NCT02660775
- Acronym / sponsor ID
- (ClaCoS) / 2015-A00580-49
- Conditions
- Schizophrenia
- Keywords
- schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Jan 2016 (estimated)
- 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.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | Experimental | Behavioral: schizophreniathis 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. |
| autism | Experimental | Behavioral: Autismthis 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. |
| healthy controls | Placebo comparator | Behavioral: Healthy controlsthis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| schizophreniaThe 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) | Behavioural | schizophrenia |
| AutismThe 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 | Behavioural | autism |
| Healthy controlsonly social cognitive measures | Behavioural | healthy controls |
Primary outcome
Change from Baseline in social cognition measures
Time frame: Week 12
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 )
2 secondary outcomes
Change from Baseline in symptoms measure
Time frame: Week 12
Change from Baseline in Neurocognitive functioning measures
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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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.
FRANCK NICOLAS, PUPH principal investigator
Service Universitaire de Réhabilitation - Le Vinatier Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing schizophrenia and Autism in people with Schizophrenia, run by Hôpital le Vinatier 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jan 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in social cognition measures (time frame: Week 12). 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 27 Jan 2022.