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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02388607
Other study ID # 5972
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2015
Est. completion date March 2023

Study information

Verified date September 2021
Source University Hospital, Strasbourg, France
Contact Dimitri Sanchez
Email drci@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is characterized by clinical symptoms combining positive and negative symptoms and thinking disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an important part in adaptation of these patients in their every-day life, and to affect their clinical symptomatology. Among them, there are deficits in sustained attention which are associated with a difficulty for these patients to maintain efficiently their cognitive activity on a source of stimulation or task. This basic attentional process is fundamental for the efficiency of the overall of cognitive processes, and so for all behaviors directed on an aim. The question of whether or not patients with schizophrenia have difficulty sustaining attention is of high relevance, in the sense that it could undermine performance on nearly any task and so provide a compelling causal explanation of many other impairments observed in these patients. Yet it has not been conclusively answered in over four decades of research. Consequently, the main objective of the protocol is to evaluate sustained attention abilities in schizophrenic patients and to better understand the specific functioning of cognitive and neural mechanisms underlying these abilities (attentional resources and cognitive control mechanisms).


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - age between 18 and 60 years (include) - men or women volunteers, hospitalized or not - subject affiliated to an health insurance - subject having signed an informed consent (for patients): - presence of DSM-IV TR criteria for schizophrenia (American Psychiatric Association, 1994) Exclusion criteria - a major somatic disorder or non stabilized - medical history likely to affect cerebral anatomy or to be linked to an abnormality (neonatal distress, neurochirurgical intervention, neurological disorders, stroke attack) - any disorders involved in the use of a psycho-active substance (as defined by the DSM-IV) - sensory disabling impairments, and specifically visual acuity < 8 - general anaesthesia during the 3 months before the study - pregnancy (declared by the subject) - persons in an emergency situation - persons deprived in any way of their liberty - persons in period of exclusion in an other protocol - use of psychotropic substance during the 3 weeks before the study - use of benzodiazepines

Study Design


Related Conditions & MeSH terms


Intervention

Other:
measurements
performance measurements

Locations

Country Name City State
France Service de psychiatrie Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess sustained attention span of patients with schizophrenia Subjects are involved in 4 different attentional tasks during which behavioral and electrophysiological measures are recorded in order to evaluate sustained attention abilities and the specific functioning of cognitive and neural mechanisms underlying these abilities in schizophrenic patients. two half-days
Secondary Study the specific mechanisms underlying attention skills supported in schizophrenic patients Subjects are involved in 4 different attentional tasks during which behavioral and electrophysiological measures are recorded in order to evaluate sustained attention abilities and the specific functioning of cognitive and neural mechanisms underlying these abilities in schizophrenic patients. two half-days
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