SchizophreniaEVACONCT02901015
Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning
A study testing Assessment battery A and Assessment battery B in people with Schizophrenia, run by Versailles Hospital at 8 sites in France.
Trial summary
Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Assessment battery A and Assessment battery B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 8 sitesFrance
- Study dates
- Apr 2013to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia or schizoaffective disorder
- Age > 18 years and < 65 years
- Patient's state allows cognitive and neuropsychological assessment
- Affiliated to a social security system (beneficiary or legal).
- Informed consent signature (patients under guardianship may be included with written permission from their legal representative).
Who cannot join
- Alcohol dependence or current toxic
- Electroconvulsivotherapy (less than 6 months)
- Serious head trauma (become unconscious), epilepsy or neurological disorder significant or evolutionary
- Invalidating and uncorrected visual disorder
- Invalidating and not paired hearing
- Actually hospitalized under constraint
- Patient not able to come to different evaluations, or who plan to change medical care in the following year
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Clermont Ferrand
Clermont-Ferrand, 63003
Hôpital Louis Mourier
Colombes, 92701
Hôpital Henri Mondor
Créteil, 94010
Centre Hospitalier de Versailles
Le Chesnay, 78150
Hôpital Sainte Marguerite
Marseille, 13274
CHRU de Montpellier
Montpellier, 34295
Centre Hospitalier Alpes Isère
Saint Egrève, 38120
CHU de Strasbourg
Strasbourg, 67098
About this study
Official title: Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.
Read the detailed description
The main objective is evaluation and validation of social cognition battery, characterizing the psychometric properties (validity, sensitivity to change) measures in a cohort of schizophrenic patients. Other objective is to demonstrate that the various components operating at T0 and T12 months of schizophrenic patients, as an external validator, are significantly explained by social cognition performance given the third known factors : neuropsychological, sociodemographic, disease course, and clinical status. Search and model relationships between the measured variables.
- Conditions
- Schizophrenia
- Being tested
- Assessment battery A, Assessment battery B
- 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.
Assessment battery ABehavioural
Social cognition tests version "A" are administered to the patients
Assessment battery BBehavioural
Social cognition tests version "B" are administered to the patients
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenic patients group 1 | Other | 80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). Receives: Behavioral: Assessment battery A |
| Schizophrenic patients group 2 | Other | 80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). Receives: Behavioral: Assessment battery B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive skills
Change in the aggregates (average) of standardized performance levels : z-scores of Theory of mind (V-COMICS, V-SIR, SPEX), z-scores of empathy (QCAE), z-scores of facial affect recognition (TREF), z-scores of metacognition (V-COMICS meta), Intelligence quotient (WAIS-III), z-scores of treatment speed, z-scores of memory spans, z-scores of verbal memory, z-scores of visual memory, z-scores of attention/vigilance, z-scores of divided attention, z-scores of executive functions.
Measured: Day 0, Month 12
Secondary outcomes (2)
Change in Functioning
Change in the aggregates (average) of standardized functioning assessment: z-scores of social functioning, z-scores of general functioning (PSPS), and z-scores of help acceptance subscales (M-SEQ)
Measured: Day 0, Month 12
Change in Psychotic symptoms
Change in the aggregates (average) of standardized symptomatology and clinical dimensions: z-scores of Schizophrenic syndromes, depressive syndrome and manic syndrome (PANSS), z-scores of observance scale (MARS/BARS), z-scores of insight (Birchwood), z-scores of antipsychotic medication doses
Measured: Day 0, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startApr 2013
- Primary completionJun 2017
- Study completionDec 2017
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric BRUNET, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901015
- Sponsor's protocol ID
- P11/34_EVACO
- Acronym
- EVACO
- Status last verified
- Mar 2018
- First submitted
- 19 Aug 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
- ClinicalTrials.gov ID
- NCT02901015
- Acronym / sponsor ID
- EVACO / P11/34_EVACO
- Conditions
- Schizophrenia
- Keywords
- schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Sep 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.
Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.
Detailed description
The main objective is evaluation and validation of social cognition battery, characterizing the psychometric properties (validity, sensitivity to change) measures in a cohort of schizophrenic patients. Other objective is to demonstrate that the various components operating at T0 and T12 months of schizophrenic patients, as an external validator, are significantly explained by social cognition performance given the third known factors : neuropsychological, sociodemographic, disease course, and clinical status. Search and model relationships between the measured variables.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenic patients group 1 | Other | Behavioral: Assessment battery A80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). |
| Schizophrenic patients group 2 | Other | Behavioral: Assessment battery B80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Schizophrenia or schizoaffective disorder
- Age > 18 years and < 65 years
- Patient's state allows cognitive and neuropsychological assessment
- Affiliated to a social security system (beneficiary or legal).
- Informed consent signature (patients under guardianship may be included with written permission from their legal representative).
Key exclusion criteria (7 listed)
- Alcohol dependence or current toxic
- Electroconvulsivotherapy (less than 6 months)
- Serious head trauma (become unconscious), epilepsy or neurological disorder significant or evolutionary
- Invalidating and uncorrected visual disorder
- Invalidating and not paired hearing
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 |
|---|---|---|
| Assessment battery ASocial cognition tests version "A" are administered to the patients | Behavioural | Schizophrenic patients group 1 |
| Assessment battery BSocial cognition tests version "B" are administered to the patients | Behavioural | Schizophrenic patients group 2 |
Primary outcome
Change in cognitive skills
Time frame: Day 0, Month 12
Change in the aggregates (average) of standardized performance levels : z-scores of Theory of mind (V-COMICS, V-SIR, SPEX), z-scores of empathy (QCAE), z-scores of facial affect recognition (TREF), z-scores of metacognition (V-COMICS meta), Intelligence quotient (WAIS-III), z-scores of treatment speed, z-scores of memory spans, z-scores of verbal memory, z-scores of visual memory, z-scores of attention/vigilance, z-scores of divided attention, z-scores of executive functions.
2 secondary outcomes
Change in Functioning
Time frame: Day 0, Month 12
Change in Psychotic symptoms
Time frame: Day 0, Month 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 22 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment battery A and Assessment battery B in people with Schizophrenia, run by Versailles Hospital at 8 sites 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 7 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. 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 in cognitive skills (time frame: Day 0, Month 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 22 Mar 2018.