Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients
NCT ID: NCT02841345
Last Updated: 2018-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
75 participants
INTERVENTIONAL
2011-12-31
2020-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Emotion Endophenotypes in Schizophrenia
NCT02834208
fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder
NCT02834182
Attention and Visual Perception in Schizophrenia: A Functional Magnetic Resonance Imaging (fMRI) Study
NCT00350935
Emotions in Schizophrenia and Bipolar Disorders: a Common Vulnerability?
NCT02805088
Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
NCT03649581
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Specifically, these are:
1. better understand what level of emotional information processing both conditions differ or are comparable and in what direction
2. assess specifically in both pathologies, emotional regulation deficits through the realization of different cognitive tasks when processing emotional information.
To answer these questions, the investigators developed an original protocol imaging functional magnetic resonance (fMRI) to specifically target different information processing channels playing on the nature of the spatial frequency content of emotional natural scenes (see Methods). emotional regulation deficits in both disorders will be addressed in part through here 3 types of tasks: 1) a simple task perception and 2) -3) two tasks categorization of which centered on the emotional feelings of the individual (task affective) and the tendency to action (motivational task). Both tasks categorization should involve more specifically the Prefrontal Cortex-Ventro Median (CPFVM) and Lateral Prefrontal Cortex-Dorso (DLPFC), respectively, distinguishing between the two categories of patients. All patient data will be compared to healthy control participants.
This project will also allow us to improve our knowledge in bipolar and schizophrenic patients compared with control subjects, i) on the brain structures of networks involved in emotional information processing and emotional regulation, ii) functional relationships still unclear between neural structures involved in both processes and iii) the nature of the information passing through these networks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bipolar
bipolar patients type I or II (DSM-IV TR), euthymic phase
behavioral and fMRI
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.
Schizophrenic
schizophrenic loss or paranoid or undifferentiated patients
behavioral and fMRI
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.
Control
control group (paired in age and sex for patients)
behavioral and fMRI
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
behavioral and fMRI
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Informed Consent signed
* Review medical and psychiatric assessment and inclusion made before participation in research
* Membership or beneficiary of a social security scheme
* Age over 18 years
* Language and French culture
* study BAC level or equivalent
* normal or corrected vision and hearing to normal
* Inpatient and outpatient
* Diagnosis of bipolar disorder type I and II DSM-IV TR (A.P.A 1994)
* Clinical Stability (inter-Critical) for at least three months with scores of ladders MADRS \<15 and YMRS \<12.
* In case of anxiety symptoms, prescription Cyanemazine® or Hydroxyzine® be allowed, at low doses (\<75 mg cyamemazine and hydroxyzyne).
* Informed Consent signed
* Review medical and psychiatric assessment and inclusion made before participation in research
* Membership or beneficiary of a social security scheme
* Age over 18 years
* Language and French culture
* study BAC level or equivalent
* normal or corrected vision and hearing to normal
* Inpatient and outpatient
* diagnosis of schizophrenic disorders such deficit, paranoid and undifferentiated
* clinical stability for three months with PANSS scores \<120 and no mood episode characterized (MADRS \<15; YMRS \<12)
Exclusion Criteria
* 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
* Patient Refusal
* Diagnosis of bipolar disorder with rapid cycling and mixed episodes
* psychiatric pathology addictive disorder or schizophrenia / schizoaffective
* neurological pathologies or progressive neurosurgical
* Personal history of seizures
* Treatment with electroconvulsive therapy (ECT) in the 6 months preceding the assessment.
* Patients hospitalized under stress or under legal protection measure (guardianship, curatorship)
* Subject deprived of liberty by judicial or administrative decision
* Contraindications to the practice of MRI equipment or incompatible metal or electronic foreign body with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat)
* significant disorders of hearing and vision
* Alcohol Ingestion
* Pregnant women, women in labor, nursing mother
schizophrenic patients
* Patient Refusal
* neurological pathologies or progressive neurosurgical
* psychiatric pathology addictive
* Patients hospitalized under stress or under legal protection measure (guardianship, curatorship)
* Subject deprived of liberty by judicial or administrative decision
* Contraindications to the practice of MRI equipment or incompatible metal or electronic foreign body with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat)
* significant disorders of hearing and vision
* Alcohol Ingestion
* Pregnant women, women in labor, nursing mother
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AURELIE CAMPAGNE, PhD
Role: STUDY_DIRECTOR
LPNC
MIRCEA POLOSAN, PhD MD Pr.
Role: PRINCIPAL_INVESTIGATOR
GrenobleUniversityHospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GrenobleUniversityHospital
La Tronche, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC11.210
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.