SchizophreniaNCT00350935
Attention and Visual Perception in Schizophrenia: A Functional Magnetic Resonance Imaging (fMRI) Study
An observational study of Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Apr 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Primary care clinic, residents of Strasbourg
Who may be able to join
- Patients with schizophrenia (DSM-IV criteria)
- Healthy controls matched with patients on age, sex and education level
- Ages 18 to 50
- Signed informed consent
- Right-handed
Who cannot join
- No severe somatic illness
- No invalidating sensory disease
- No drug abuse, as defined by DSM-IV criteria
- No general anaesthesia in the past 3 months
- No intake of drugs affecting the CNS, except for patients
Trial locations and contacts
1 site in 1 country.
France1 site
Inserm U666 - Département de Psychiatrie, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Attention and Grouping of Visual Information: What is Disturbed in Patients With Schizophrenia?
The main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. Processing visual information involves both automatic grouping processes and control processes. Automatic grouping processes allow the building of a global configuration from local contour information. It is necessary in order to recognize objects. Control processes allow tending to and prioritizing information parts. The paradigm the investigators use allows to dissociate these processes, and is used in order to characterize the impairments observed in patients with schizophrenia. It is adapted to fMRI in order to explore the neurobiological basis of the deficits. The investigators will examine whether functional disconnectivity between activated areas subtend the impairments observed in patients.
- Conditions
- Schizophrenia
- Being tested
- fMRI
- Keywords
- fMRI, Visual perception, Attention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
One 30 minute session
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy controls Receives: Procedure: fMRI | |
| Patients | Patients with schizophrenia Receives: Procedure: fMRI |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startSep 2006
- Study completionApr 2009
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.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Région Alsace, Faculté de Médecine de Strasbourg
- Investigators
- Anne Giersch, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350935
- Sponsor's protocol ID
- 3456
- Status last verified
- Jun 2010
- First submitted
- 10 Jul 2006
- Last updated
- 28 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention and Grouping of Visual Information: What is Disturbed in Patients With Schizophrenia?
- ClinicalTrials.gov ID
- NCT00350935
- Acronym / sponsor ID
- 3456
- Conditions
- Schizophrenia
- Keywords
- fMRI, Visual perception, Attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Région Alsace, Faculté de Médecine de Strasbourg
- Study start
- Sep 2006
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Jul 2006 (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.
The main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. Processing visual information involves both automatic grouping processes and control processes. Automatic grouping processes allow the building of a global configuration from local contour information. It is necessary in order to recognize objects. Control processes allow tending to and prioritizing information parts. The paradigm the investigators use allows to dissociate these processes, and is used in order to characterize the impairments observed in patients with schizophrenia. It is adapted to fMRI in order to explore the neurobiological basis of the deficits. The investigators will examine whether functional disconnectivity between activated areas subtend the impairments observed in patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Procedure: fMRIHealthy controls |
| Patients | – | Procedure: fMRIPatients with schizophrenia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primary care clinic, residents of Strasbourg
Key inclusion criteria (5 listed)
- Patients with schizophrenia (DSM-IV criteria)
- Healthy controls matched with patients on age, sex and education level
- Ages 18 to 50
- Signed informed consent
- Right-handed
Key exclusion criteria (5 listed)
- No severe somatic illness
- No invalidating sensory disease
- No drug abuse, as defined by DSM-IV criteria
- No general anaesthesia in the past 3 months
- No intake of drugs affecting the CNS, except for patients
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 |
|---|---|---|
| fMRIOne 30 minute session | Procedure or surgery | Healthy volunteers, Patients |
Primary outcome
Not reported in the source record.
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 28 Jun 2010.
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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.
Anne Giersch, MD principal investigator
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 Schizophrenia, 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 5 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 28 Jun 2010. 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?
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.
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 28 Jun 2010.