Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatments assessment battery a, assessment battery b
Sponsor Versailles Hospital
Start date April 2013
End date June 2017
Trial size 160 participants
Trial identifier NCT02901015, P11/34_EVACO

Summary

Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).
assessment battery a
Social cognition tests version "A" are administered to the patients
(Other)
80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).
assessment battery b
Social cognition tests version "B" are administered to the patients

Primary Outcomes

Measure
Change in cognitive skills
time frame: Day 0, Month 12

Secondary Outcomes

Measure
Change in Functioning
time frame: Day 0, Month 12
Change in Psychotic symptoms
time frame: Day 0, Month 12

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 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). Exclusion Criteria: - 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

Additional Information

Official title Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
Principal investigator Eric BRUNET, Psychiatre
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Versailles Hospital.