SchizophreniaERPs-PSYNCT02329119
Psychiatric Disorders and Electrophysiological Markers
A study testing electrophysiological recordings in people with Schizophrenia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Schizophrenia is considered as the most frequent and the most severe chronic psychotic disorder. Its evolutionary modes and its clinical symptomatology remain particularly heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from being clearly understood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- electrophysiological recordings
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Feb 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject showing no severe or progressive somatic pathology, including neurological pathology (head injury, epilepsy, tumor process or multiple sclerosis causing EEG changes incompatible with the observation of ERP characteristics of both psychiatric disorders explored)
- Subject showing a diagnosis of schizophrenia or a diagnosis of bipolar affective disorders, as defined in the DSM IV-TR, in time of inclusion.
- Subject showing no disorder related to the use of a substance according to DSM IV-TR during the last 12 months prior to enrollment.
- Subject not showing another psychiatric disorder according to DSM IV-TR (axis 1 disorders), including schizoaffective disorder or a delusional disorder (not schizophrenic).
Who cannot join
- Subject unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Michel CERMOLACCE, Dr contact
France1 site
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Michel Cermolacce, michel.cermolacce@ap-hm.fr
About this study
Schizophrenia is considered as the most frequent and the most severe chronic psychotic disorder. Its evolutionary modes and its clinical symptomatology remain particularly heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from being clearly understood. Current empirical studies provide a mean duration comprised between 1 and 3 years without any specific diagnosis or treatment. These diagnosis issues are partly based on difficulties in the early distinction between schizophrenia and bipolar affective disorders (BD).
These results emphasize the necessity of new early indices (or endophenotypes). Such markers are intended to be more specific than classical clinical manifestations. In other words, they have to be absent among patients with differential diagnosis, such as BD. Among other possible early indices, several electrophysiological disturbances have been explored.
Read more
Our study is designed to mainly describe the N400 component among patients with schizophrenia or BD. This component is classically interpreted as indexing the integration the meaning of a linguistic stimulus in its preceding context. Our main hypothesis aims to show a specific alteration of N400 component among patients with schizophrenia when compared to participants with BD.
The second aim of this study concerns the exploration of four other event related potentials (ERPs) among patients with schizophrenia or BD:
- the P50 component, involved in early sensory gating processes,
- the P300 component, thought to reflect attentional resource allocation and working memory updating of stimulus context,
- the P600 component, elicited during same paradigms than N400, and reflecting their syntactic congruity.
- the CNV (Contingent Negative Variation), reflecting processes of motor anticipation
Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400 and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also propose to describe the possible relations between these ERPs results and clinical scores observed among patients.
- Conditions
- Schizophrenia
- Being tested
- electrophysiological recordings
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiological recordingsOther
| Study group | Role | What they receive |
|---|---|---|
| G1-SCZ | Experimental | patients with schizophrenia as defined in DSM IV-TR Receives: Other: electrophysiological recordings |
| G2-TAB | Active comparator | patients with bipolar affective disorder (BD) type I as defined by the DSM IV-TR Receives: Other: electrophysiological recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP)
amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP) recorded from nine electrodes. For each subject, the average of the amplitude of the nine electrodes is calculated and represents the synthetic parameter for amplitude N400.This is a quantitative parameter. Values will be compared between the two groups of subjects (G1-SCZ and G2-TAB).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startSep 2015
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (estimated)
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 Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329119
- Sponsor's protocol ID
- 2014-07
- Other IDs
- RCAPHM14_0077
- Acronym
- ERPs-PSY
- Status last verified
- Aug 2015
- First submitted
- 26 Dec 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Disorders and Electrophysiological Markers
- ClinicalTrials.gov ID
- NCT02329119
- Acronym / sponsor ID
- ERPs-PSY / 2014-07
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 31 Dec 2014 (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 considered as the most frequent and the most severe chronic psychotic disorder. Its evolutionary modes and its clinical symptomatology remain particularly heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from being clearly understood. Current empirical studies provide a mean duration comprised between 1 and 3 years without any specific diagnosis or treatment. These diagnosis issues are partly based on difficulties in the early distinction between schizophrenia and bipolar affective disorders (BD).
These results emphasize the necessity of new early indices (or endophenotypes). Such markers are intended to be more specific than classical clinical manifestations. In other words, they have to be absent among patients with differential diagnosis, such as BD. Among other possible early indices, several electrophysiological disturbances have been explored.
Our study is designed to mainly describe the N400 component among patients with schizophrenia or BD. This component is classically interpreted as indexing the integration the meaning of a linguistic stimulus in its preceding context. Our main hypothesis aims to show a specific alteration of N400 component among patients with schizophrenia when compared to participants with BD.
The second aim of this study concerns the exploration of four other event related potentials (ERPs) among patients with schizophrenia or BD:
- the P50 component, involved in early sensory gating processes,
- the P300 component, thought to reflect attentional resource allocation and working memory updating of stimulus context,
- the P600 component, elicited during same paradigms than N400, and reflecting their syntactic congruity.
- the CNV (Contingent Negative Variation), reflecting processes of motor anticipation
Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400 and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also propose to describe the possible relations between these ERPs results and clinical scores observed among patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1-SCZ | Experimental | Other: electrophysiological recordingspatients with schizophrenia as defined in DSM IV-TR |
| G2-TAB | Active comparator | Other: electrophysiological recordingspatients with bipolar affective disorder (BD) type I as defined by the DSM IV-TR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject showing no severe or progressive somatic pathology, including neurological pathology (head injury, epilepsy, tumor process or multiple sclerosis causing EEG changes incompatible with the observation of ERP characteristics of both psychiatric disorders explored)
- Subject showing a diagnosis of schizophrenia or a diagnosis of bipolar affective disorders, as defined in the DSM IV-TR, in time of inclusion.
- Subject showing no disorder related to the use of a substance according to DSM IV-TR during the last 12 months prior to enrollment.
- Subject not showing another psychiatric disorder according to DSM IV-TR (axis 1 disorders), including schizoaffective disorder or a delusional disorder (not schizophrenic).
Key exclusion criteria (1 listed)
- Subject unable to give informed consent
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 |
|---|---|---|
| electrophysiological recordings | Other | G1-SCZ, G2-TAB |
Primary outcome
amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP)
Time frame: 1 day
amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP) recorded from nine electrodes. For each subject, the average of the amplitude of the nine electrodes is calculated and represents the synthetic parameter for amplitude N400.This is a quantitative parameter. Values will be compared between the two groups of subjects (G1-SCZ and G2-TAB).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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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.
Michel CERMOLACCE, Dr contact
Urielle DESALBRES study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrophysiological recordings in people with Schizophrenia, run by Assistance Publique Hopitaux De Marseille 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 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2015. 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 Michel CERMOLACCE, Dr (michel.cermolacce@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amplitude (in µV) of negativity observed the highest between 250 and 500 ms for the N400 component of Event Related Potentials (ERP) (time frame: 1 day). 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 21 Aug 2015.