Bipolar DisorderELISENCT02805088
Emotions in Schizophrenia and Bipolar Disorders: a Common Vulnerability?
A study testing Electroencephalographic recordings, neuropsychological evaluation and clinical evaluation of symptoms in people with Bipolar Disorder and Schizophrenia, run by CHU de Reims at 1 site in France.
Trial summary
The initial aim of the project was to gain an understanding of the comprehension of "language-oriented" emotions among schizophrenic and bipolar patients. By "language-oriented" emotions, the investigators mean the emotions that are conveyed by means of language, whether through the emotional valence of the words, the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- What is being tested?
- Electroencephalographic recordings, neuropsychological evaluation and clinical evaluation of symptoms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients :
- Men or women, right-handed, with a diagnosis of bipolar disorder or schizophrenia, according to the DSM-IV criteria, aged from 18 to 65 years-old Native French speaker Clinically stabilised Able to provide informed written and verbal consent
- Healthy Controls :
- Men or women, right-handed, aged from 18 to 65 years-old Native French speaker Able to provide informed written and verbal consent
Who cannot join
- Patients :
- A recent alcohol and/or drug abuse or dependence A significant general medical illness, including neurological disorders or head trauma A sensorial impairment (visual and/or hearing)
- Healthy Controls :
- A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV A recent alcohol and/or drug abuse or dependence A significant general medical illness, including neurological disorders or head trauma A sensorial impairment (visual and/or hearing)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
France, Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Interaction Emotion-cognition in the Study of Literal and Figurative Language in Schizophrenia and Bipolar Disorders: Behavioral and Electrophysiological Studies
The initial aim of the project was to gain an understanding of the comprehension of "language-oriented" emotions among schizophrenic and bipolar patients. By "language-oriented" emotions, the investigators mean the emotions that are conveyed by means of language, whether through the emotional valence of the words, the expression of an emotional state or emotional prosody. Although they involve different diagnostic categories, schizophrenic and bipolar disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and do so to such an extent that the question of whether there may, at the clinical, cognitive and etiopathogenic levels, exist a continuum between these disorders is frequently raised. Taking this hypothesis of a clinical continuum as our starting point, the investigators explored the understanding of emotions contextualized by language in these two clinical populations, namely patients exhibiting schizophrenic and bipolar disorders. To these populations, the investigators also added the dimension of vulnerability in the form of non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus orienting this project toward the early identification of cognitive-emotional markers and possibly also their prevention.
Read the detailed description
The aim of this proposal is to investigate disturbances of understanding of "emotional language" in schizophrenia and bipolar disorder. By "emotional langague", the investigators mean emotions wich can be drawn from utterances, thanks to affective valence of words or phrases, expression of emotional state or prosody. Schizophrenia and bipolar disorder share several symptoms, particularly those related to emotional sphere, in such a way that it is frequently asked whether these disorders could be formalized on a continuum. Comparing the cognitive-emotional functioning of these two kinds of patients should allow identifying cognitive markers of the psychotic symptom dimension common in both diseases.
On the basis of the abundant literature regarding cognitive-emotional functioning in schizophrenia and on the more infrequent literature concerning bipolar functioning, the investigators hypothesized that the difficulties in processing emotions, in attributing intentionality and in integrating information for meaning are markers for the psychotic symptom dimension common in both pathologies. To test this hypothesis, the investigators chose to investigate language understanding because it can imply a semantic-emotional processing and because it necessitates integration processes. The integration processes obligatory operate on semantic information, from which it can be added, in ecological situations, prosodic and intentional information. The proposed methodology involves different levels of language, requiring more or less complex integration processes - literal language and figurative language - and different emotional features - affective valence of words and expressions and emotional prosody -.
The investigators plan to conduct behavioral and electrophysiological (event-related potentials) studies. For the later, The investigators will focus on electrophysiological components well known to be implied in language and emotional processing: the N400, the LPC (Late Positive Component) and the LPP (Late Positive Potential). The combination of behavioral and electrophysiological indicators will allow the identification of the neurocognitive mechanisms shared by both schizophrenic and bipolar patients, particularly those who experienced a psychotic episode, in comparison with those of healthy participants. These studies will be conducted on 60 stable schizophrenic patients, 60 euthymic bipolar patients with or without psychotic symptoms, and 120 healthy participants, matched on age and educational achievement level to each pathological group. Different instruments will be used to investigate, in both pathological groups and their controls, different emotional dimensions (anhedonia, alexithymia, positive or negative affectivity, depression, anxiety). Investigating the cognitive-emotional functioning of patients from a dimensional approach (psychotic symptom dimension) rather than from a categorical approach could impulse a new way of thinking diagnosis or identifying factors of vulnerability and protection for these diseases.
- Conditions
- Bipolar Disorder, Schizophrenia
- Being tested
- Electroencephalographic recordings, neuropsychological evaluation, clinical evaluation of symptoms
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalographic recordingsOther
neuropsychological evaluationOther
clinical evaluation of symptomsOther
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder patients | Experimental | Not described Receives: Other: Electroencephalographic recordings; Other: neuropsychological evaluation; Other: clinical evaluation of symptoms |
| Schizophrenia patients | Experimental | Not described Receives: Other: Electroencephalographic recordings; Other: neuropsychological evaluation; Other: clinical evaluation of symptoms |
| Healthy Volunteers | Experimental | Not described Receives: Other: Electroencephalographic recordings; Other: neuropsychological evaluation; Other: clinical evaluation of symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-related brain potentials (ERP)
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805088
- Sponsor's protocol ID
- PO13116
- Acronym
- ELISE
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Publications
Terrien S, Gobin P, Iakimova G, Coutte A, Thuaire F, Baltazart V, Mazzola-Pomietto P, Besche-Richard C. Electrophysiological correlates of emotional meaning in context in relation to facets of schizotypal personality traits: A dimensional study. Psychiatry Clin Neurosci. 2016 Mar;70(3):141-50. doi: 10.1111/pcn.12366. Epub 2015 Dec 22.
PubMed 26482112Terrien S, Gobin P, Coutte A, Thuaire F, Iakimova G, Mazzola-Pomietto P, Besche-Richard C. Emotional Meaning in Context in Relation to Hypomanic Personality Traits: An ERP Study. PLoS One. 2015 Sep 22;10(9):e0138877. doi: 10.1371/journal.pone.0138877. eCollection 2015.
PubMed 26394230Terrien S, Stefaniak N, Morvan Y, Besche-Richard C. Factor structure of the French version of the Hypomanic Personality Scale (HPS) in non-clinical young adults. Compr Psychiatry. 2015 Oct;62:105-13. doi: 10.1016/j.comppsych.2015.07.001. Epub 2015 Jul 8.
PubMed 26343474
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Emotion-cognition in the Study of Literal and Figurative Language in Schizophrenia and Bipolar Disorders: Behavioral and Electrophysiological Studies
- ClinicalTrials.gov ID
- NCT02805088
- Acronym / sponsor ID
- ELISE / PO13116
- Conditions
- Bipolar Disorder, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2016 (estimated)
- First posted
- 17 Jun 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.
The initial aim of the project was to gain an understanding of the comprehension of "language-oriented" emotions among schizophrenic and bipolar patients. By "language-oriented" emotions, the investigators mean the emotions that are conveyed by means of language, whether through the emotional valence of the words, the expression of an emotional state or emotional prosody. Although they involve different diagnostic categories, schizophrenic and bipolar disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and do so to such an extent that the question of whether there may, at the clinical, cognitive and etiopathogenic levels, exist a continuum between these disorders is frequently raised. Taking this hypothesis of a clinical continuum as our starting point, the investigators explored the understanding of emotions contextualized by language in these two clinical populations, namely patients exhibiting schizophrenic and bipolar disorders. To these populations, the investigators also added the dimension of vulnerability in the form of non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus orienting this project toward the early identification of cognitive-emotional markers and possibly also their prevention.
Detailed description
The aim of this proposal is to investigate disturbances of understanding of "emotional language" in schizophrenia and bipolar disorder. By "emotional langague", the investigators mean emotions wich can be drawn from utterances, thanks to affective valence of words or phrases, expression of emotional state or prosody. Schizophrenia and bipolar disorder share several symptoms, particularly those related to emotional sphere, in such a way that it is frequently asked whether these disorders could be formalized on a continuum. Comparing the cognitive-emotional functioning of these two kinds of patients should allow identifying cognitive markers of the psychotic symptom dimension common in both diseases.
On the basis of the abundant literature regarding cognitive-emotional functioning in schizophrenia and on the more infrequent literature concerning bipolar functioning, the investigators hypothesized that the difficulties in processing emotions, in attributing intentionality and in integrating information for meaning are markers for the psychotic symptom dimension common in both pathologies. To test this hypothesis, the investigators chose to investigate language understanding because it can imply a semantic-emotional processing and because it necessitates integration processes. The integration processes obligatory operate on semantic information, from which it can be added, in ecological situations, prosodic and intentional information. The proposed methodology involves different levels of language, requiring more or less complex integration processes - literal language and figurative language - and different emotional features - affective valence of words and expressions and emotional prosody -.
The investigators plan to conduct behavioral and electrophysiological (event-related potentials) studies. For the later, The investigators will focus on electrophysiological components well known to be implied in language and emotional processing: the N400, the LPC (Late Positive Component) and the LPP (Late Positive Potential). The combination of behavioral and electrophysiological indicators will allow the identification of the neurocognitive mechanisms shared by both schizophrenic and bipolar patients, particularly those who experienced a psychotic episode, in comparison with those of healthy participants. These studies will be conducted on 60 stable schizophrenic patients, 60 euthymic bipolar patients with or without psychotic symptoms, and 120 healthy participants, matched on age and educational achievement level to each pathological group. Different instruments will be used to investigate, in both pathological groups and their controls, different emotional dimensions (anhedonia, alexithymia, positive or negative affectivity, depression, anxiety). Investigating the cognitive-emotional functioning of patients from a dimensional approach (psychotic symptom dimension) rather than from a categorical approach could impulse a new way of thinking diagnosis or identifying factors of vulnerability and protection for these diseases.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder patients | Experimental | Other: Electroencephalographic recordings, Other: neuropsychological evaluation, Other: clinical evaluation of symptoms |
| Schizophrenia patients | Experimental | Other: Electroencephalographic recordings, Other: neuropsychological evaluation, Other: clinical evaluation of symptoms |
| Healthy Volunteers | Experimental | Other: Electroencephalographic recordings, Other: neuropsychological evaluation, Other: clinical evaluation of symptoms |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women, right-handed, with a diagnosis of bipolar disorder or schizophrenia, according to the DSM-IV criteria, aged from 18 to 65 years-old Native French speaker Clinically stabilised Able to provide informed written and verbal consent
- Men or women, right-handed, aged from 18 to 65 years-old Native French speaker Able to provide informed written and verbal consent
Key exclusion criteria (4 listed)
- A recent alcohol and/or drug abuse or dependence A significant general medical illness, including neurological disorders or head trauma A sensorial impairment (visual and/or hearing)
- A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV A recent alcohol and/or drug abuse or dependence A significant general medical illness, including neurological disorders or head trauma A sensorial impairment (visual and/or hearing)
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 |
|---|---|---|
| Electroencephalographic recordings | Other | Bipolar Disorder patients, Healthy Volunteers, Schizophrenia patients |
| neuropsychological evaluation | Other | Bipolar Disorder patients, Healthy Volunteers, Schizophrenia patients |
| clinical evaluation of symptoms | Other | Bipolar Disorder patients, Healthy Volunteers, Schizophrenia patients |
Primary outcome
Event-related brain potentials (ERP)
Time frame: within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Results publication: PubMed 26482112Terrien S, Gobin P, Iakimova G, Coutte A, Thuaire F, Baltazart V, Mazzola-Pomietto P, Besche-Richard C. Electrophysiological correlates of emotional meaning in context in relation to facets of schizotypal personality traits: A dimensional study. Psychiatry Clin Neurosci. 2016 Mar;70(3):141-50. doi: 10.1111/pcn.12366. Epub 2015 Dec 22.
- Results publication: PubMed 26394230Terrien S, Gobin P, Coutte A, Thuaire F, Iakimova G, Mazzola-Pomietto P, Besche-Richard C. Emotional Meaning in Context in Relation to Hypomanic Personality Traits: An ERP Study. PLoS One. 2015 Sep 22;10(9):e0138877. doi: 10.1371/journal.pone.0138877. eCollection 2015.
- Results publication: PubMed 26343474Terrien S, Stefaniak N, Morvan Y, Besche-Richard C. Factor structure of the French version of the Hypomanic Personality Scale (HPS) in non-clinical young adults. Compr Psychiatry. 2015 Oct;62:105-13. doi: 10.1016/j.comppsych.2015.07.001. Epub 2015 Jul 8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalographic recordings, neuropsychological evaluation and clinical evaluation of symptoms in people with Bipolar Disorder and Schizophrenia, run by CHU de Reims 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 4 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 Jun 2016. 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 Arthur KALADJIAN (326787045 ext. 33, akaladjian@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-related brain potentials (ERP) (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805088, which also lists 3 linked publications.
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 Jun 2016.