Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients (EMOBISCHI)

October 10, 2018 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Main goals This research project generally aims to refine our understanding of the similarities and distinctions between bipolar and schizophrenic patients in emotional information processing.

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

healthy volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Inclusion criteria

  • 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

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bipolar
bipolar patients type I or II (DSM-IV TR), euthymic phase

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.
Other: Schizophrenic
schizophrenic loss or paranoid or undifferentiated patients

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.
Other: Control
control group (paired in age and sex for patients)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric evaluation
Time Frame: 70 minutes
PANSS - POSITIVE AND NEGATIVE SYNDROME SCALE Scale with 30 items
70 minutes
Psychometric evaluation
Time Frame: 15 minutes
MADRS - Montgomery Asberg Depression Rating
15 minutes
Psychometric evaluation
Time Frame: 15 minutes
YMRS - Young Mania Rating Scale
15 minutes
Self-Questionnaire
Time Frame: Few hours
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
Time Frame: 15 minutes
CPT II - Conners' Continuous Performance Test II
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: AURELIE CAMPAGNE, PhD, LPNC
  • Principal Investigator: MIRCEA POLOSAN, PhD MD Pr., GrenobleUniversityHospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

February 29, 2020

Study Completion (Anticipated)

February 29, 2020

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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