Schizophrenic PsychosesACCRASNCT02388607
Sustained Attention Abilities in Schizophrenia
An observational study of Schizophrenic Psychoses, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenic Psychoses
- What is being tested?
- measurements
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Mar 2023
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 40 schizophrenic patients versus 40 healthy subjects matched
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Dimitri Sanchez contact
France1 site, 1 recruiting
- Recruiting
Service de psychiatrie
Strasbourg, 67000
Anne Giersch, MD, anne.giersch@chru-strasbourg.fr
About this study
Official title: 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).
- Conditions
- Schizophrenic Psychoses
- Being tested
- measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurementsOther
performance measurements
| Study group | Role | What they receive |
|---|---|---|
| assessing attention span | * Electrophysiological measurements (evocated potentials and spectral densities)
* Clinical scales and subjective assessments of difficulty of the tasks performed, and commitment to the task Receives: Other: measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two half-days
Secondary outcomes (1)
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.
Measured: two half-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic PsychosesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giersch Anne, MD, Principal investigator, Les Hôpitaux Universitaires de StrasbourgBonnefond Anne, PHD, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388607
- Sponsor's protocol ID
- 5972
- Acronym
- ACCRAS
- Status last verified
- Sep 2021
- First submitted
- 10 Dec 2014
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Attention Abilities, Attentional Resources and Cognitive Control Mechanisms in Schizophrenia
- ClinicalTrials.gov ID
- NCT02388607
- Acronym / sponsor ID
- ACCRAS / 5972
- Conditions
- Schizophrenic Psychoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 17 Mar 2015 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessing attention span | – | Other: measurements* Electrophysiological measurements (evocated potentials and spectral densities) * Clinical scales and subjective assessments of difficulty of the tasks performed, and commitment to the task |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 schizophrenic patients versus 40 healthy subjects matched
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| measurementsperformance measurements | Other | assessing attention span |
Primary outcome
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.
1 secondary outcome
Study the specific mechanisms underlying attention skills supported in schizophrenic patients
Time frame: two half-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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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.
Dimitri Sanchez contact
Giersch Anne, MD principal investigator
Les Hôpitaux Universitaires de Strasbourg
Bonnefond Anne, PHD study chair
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenic Psychoses, run by University Hospital, Strasbourg, France 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 11 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: status not confirmed, as of the sponsor's last update on 14 Sep 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitri Sanchez (drci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess sustained attention span of patients with schizophrenia (time frame: two half-days). 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 14 Sep 2021.