Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients
EMOBISCHI
1 other identifier
interventional
75
1 country
1
Brief Summary
In the case of psychotic disorders such as bipolar disorder or schizophrenia, attention dysfunction contribute, according to the theories of neuroscience, the development of mood disorders following disturbances in the interaction-care emotion. In this context, the general objective of this research project is to refine our understanding of the similarities and distinctions between bipolar and schizophrenic patients in the basic emotional information processing. Specifically, these are: 1) to better understand what level of basic emotional information processing both conditions differ or are comparable and in what sense and 2) estimate, in both pathologies, the specific influence of the nature of the task of processing emotional information. To answer these questions, the investigators have developed a protocol to specifically target different information processing channels playing on the nature of the spatial frequency content of emotional natural scenes. To estimate in both pathologies, the specific influence of the nature of the task on emotional processing, 3 types of tasks are proposed: 1) a simple task perception and 2) -3) two tasks whose categorization one focused on the emotional feelings of the individual and the other on the tendency to action. Both tasks categorization should involve more specifically the ventromedial prefrontal cortex (CPFVM) and the dorsolateral prefrontal cortex (DLPFC) respectively. All patient data will be compared with data from healthy control participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Dec 2011
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2020
CompletedOctober 11, 2018
October 1, 2018
8.3 years
June 16, 2016
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Psychometric evaluation
PANSS - POSITIVE AND NEGATIVE SYNDROME SCALE Scale with 30 items
70 minutes
Psychometric evaluation
MADRS - Montgomery Asberg Depression Rating
15 minutes
Psychometric evaluation
YMRS - Young Mania Rating Scale
15 minutes
Self-Questionnaire
SHAPS - Snaith-Hamilton Pleasure Scale Starkstein STAI Y - State-Trait Anxiety Inventory AIM: "affect intensity measure" ALS: "affective lability scale" MATHYS
Few hours
Cognitive questionnaire
CPT II - Conners' Continuous Performance Test II
15 minutes
Study Arms (3)
Bipolar
OTHERbipolar patients type I or II (DSM-IV TR), euthymic phase
Schizophrenic
OTHERschizophrenic loss or paranoid or undifferentiated patients
Control
OTHERcontrol group (paired in age and sex for patients)
Interventions
The experience will include 3 sessions. Each session will consist of the presentation of a pseudo-random sequence of 24 black and white images of negative emotional natural scenes, 24 positive emotional situations and 24 neutral emotional situations. * In the first session, participants will carry out an emotional assessment task: it will show at the end of each test his emotional feeling - pleasant, unpleasant or nothing - using a joystick. * In a second session, the participant will perform a motor task decision: it will show at the end of each test the tendency to action he would handle the situation actually using 3 buttons également- approach withdrawal or neither one nor the other. * In the third session, the participant will perform a simple visual perception task. To be comparable to the engine plane with the other sessions, a non-categorical motor task will be requested from participants.
Eligibility Criteria
You may qualify if:
- Informed Consent signed
- Medical examination conducted before research participation
- Age, sex and level of education paired with bipolar and schizophrenic patients)
- French Language and Culture
- normal or corrected vision and hearing to normal
- affiliate Obligation to social security
You may not qualify if:
- Topic included in an ongoing experiment
- contraindication to MRI (metal hardware or electronic incompatible with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat)
- Important Hearing Disorders and vision
- neurological pathologies or past or current neuropsychiatric
- Family history of psychiatric disorders
- Drug treatment may modulate brain activity: benzodiazepines, antidepressants, neuroleptics, etc.
- Alcohol Ingestion
- Pregnant women, women in labor, nursing mother
- All other categories of protected persons
- bipolar patients
- Informed Consent signed
- Membership or beneficiary of a social security scheme
- Age over 18 years
- Language and French culture
- study BAC level or equivalent
- +36 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GrenobleUniversityHospital
La Tronche, 38700, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AURELIE CAMPAGNE, PhD
LPNC
- PRINCIPAL INVESTIGATOR
MIRCEA POLOSAN, PhD MD Pr.
GrenobleUniversityHospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2016
First Posted
July 22, 2016
Study Start
December 1, 2011
Primary Completion
February 29, 2020
Study Completion
February 29, 2020
Last Updated
October 11, 2018
Record last verified: 2018-10