SchizophreniaSERCNCT02896374
Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia
A study testing Theory of mind without visual cues in people with Schizophrenia, run by Versailles Hospital at 1 site in France.
Trial summary
Case-control comparison of clinical population, interventional and single-center research. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Theory of mind without visual cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group
Who cannot join
- Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia
Case-control comparison of clinical population, interventional and single-center research.
Read the detailed description
The main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. Two groups of subjects are recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during theory of mind judgment is tested.
- Conditions
- Schizophrenia
- Being tested
- Theory of mind without visual cues
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory of mind without visual cuesBehavioural
Theory of mind stimulation without visual reinforcement while performing EEG recordings
Theory of mind without visual cuesBehavioural
Theory of mind stimulation with visual reinforcement while performing EEG recordings
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Treated or hospitalized patients for schizophrenia. Receives: Behavioral: Theory of mind without visual cues |
| Control | Experimental | No schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ. Receives: Behavioral: Theory of mind without visual cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event related electric amplitudes
Scalp EEG recordings (microvolts) with respect to average or vertex references
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startMar 2013
- Primary completionJun 2017
- Study completionDec 2017
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric BRUNET, Versailles Hospital
- Investigators
- Eric Brunet, MD PhD, Principal investigator, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896374
- Sponsor's protocol ID
- P11/16_SERC
- Acronym
- SERC
- Status last verified
- Mar 2018
- First submitted
- 19 Aug 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia
- ClinicalTrials.gov ID
- NCT02896374
- Acronym / sponsor ID
- SERC / P11/16_SERC
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Sep 2016 (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.
Case-control comparison of clinical population, interventional and single-center research.
Detailed description
The main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. Two groups of subjects are recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during theory of mind judgment is tested.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Behavioral: Theory of mind without visual cuesTreated or hospitalized patients for schizophrenia. |
| Control | Experimental | Behavioral: Theory of mind without visual cuesNo schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group
Key exclusion criteria (1 listed)
- Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device
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 |
|---|---|---|
| Theory of mind without visual cuesTheory of mind stimulation without visual reinforcement while performing EEG recordings | Behavioural | Control, Patients |
| Theory of mind without visual cuesTheory of mind stimulation with visual reinforcement while performing EEG recordings | Behavioural | Control, Patients |
Primary outcome
Event related electric amplitudes
Time frame: Day 0
Scalp EEG recordings (microvolts) with respect to average or vertex references
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 22 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Eric Brunet, MD PhD principal investigator
Versailles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory of mind without visual cues in people with Schizophrenia, run by Versailles Hospital 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 1 inclusion and 1 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 22 Mar 2018. 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.
What does the primary outcome measure?
Event related electric amplitudes (time frame: Day 0). 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 22 Mar 2018.