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Emotions in Schizophrenia and Bipolar Disorders: a Common Vulnerability? (ELISE)

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ClinicalTrials.gov Identifier: NCT02805088
Recruitment Status : Unknown
Verified June 2016 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Schizophrenia Other: Electroencephalographic recordings Other: neuropsychological evaluation Other: clinical evaluation of symptoms Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Interaction Emotion-cognition in the Study of Literal and Figurative Language in Schizophrenia and Bipolar Disorders: Behavioral and Electrophysiological Studies
Study Start Date : February 2014
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bipolar Disorder patients Other: Electroencephalographic recordings
Other: neuropsychological evaluation
Other: clinical evaluation of symptoms
Experimental: Schizophrenia patients Other: Electroencephalographic recordings
Other: neuropsychological evaluation
Other: clinical evaluation of symptoms
Experimental: Healthy Volunteers Other: Electroencephalographic recordings
Other: neuropsychological evaluation
Other: clinical evaluation of symptoms



Primary Outcome Measures :
  1. Event-related brain potentials (ERP) [ Time Frame: within 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

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

Exclusion criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805088


Contacts
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Contact: Arthur KALADJIAN 326787045 ext 33 akaladjian@chu-reims.fr

Locations
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France
Chu Reims Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
Publications of Results:
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02805088    
Other Study ID Numbers: PO13116
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders