Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients

NCT ID: NCT02841345

Last Updated: 2018-10-11

Study Results

Results pending

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.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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

Group Type OTHER

behavioral and fMRI

Intervention Type OTHER

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

Group Type OTHER

behavioral and fMRI

Intervention Type OTHER

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)

Group Type OTHER

behavioral and fMRI

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

VANESSA ESPIN

Role: CONTACT

4 76 76 68 13 ext. +33 (0)

EMILIE COUSIN, PhD

Role: CONTACT

0 13 63 86 45

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

MIRCEA POLOSAN, PhD MD Pr.

Role: primary

4 76 76 53 ext. +33 (0)

AURELIE CAMPAGNE, PhD

Role: backup

4 56 52 85 08 ext. +33 (0)

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.