- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388607
Sustained Attention Abilities in Schizophrenia (ACCRAS)
September 13, 2021 updated by: University Hospital, Strasbourg, France
Sustained Attention Abilities, Attentional Resources and Cognitive Control Mechanisms in Schizophrenia
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).
Study Overview
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dimitri Sanchez
- Email: drci@chru-strasbourg.fr
Study Locations
-
-
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Strasbourg, France, 67000
- Recruiting
- Service de psychiatrie
-
Contact:
- Anne Giersch, MD
- Email: anne.giersch@chru-strasbourg.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
40 schizophrenic patients versus 40 healthy subjects matched
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
assessing attention span
|
performance measurements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess sustained attention span of patients with schizophrenia
Time Frame: two half-days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study the specific mechanisms underlying attention skills supported in schizophrenic patients
Time Frame: two half-days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Giersch Anne, MD, Les Hôpitaux Universitaires de Strasbourg
- Study Chair: Bonnefond Anne, PHD, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
December 10, 2014
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5972
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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