- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841345
Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients (EMOBISCHI)
Study Overview
Status
Conditions
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:
- better understand what level of emotional information processing both conditions differ or are comparable and in what direction
- 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
La Tronche, France, 38700
- Recruiting
- GrenobleUniversityHospital
-
Contact:
- MIRCEA POLOSAN, PhD MD Pr.
- Phone Number: +33 (0) 4 76 76 53
- Email: mpolosan@chu-grenoble.fr
-
Contact:
- AURELIE CAMPAGNE, PhD
- Phone Number: +33 (0) 4 56 52 85 08
- Email: aurelie.campagne@univ-grenoble-alpes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
|
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.
|
|
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.
|
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
Sponsor
Investigators
- Study Director: AURELIE CAMPAGNE, PhD, LPNC
- Principal Investigator: MIRCEA POLOSAN, PhD MD Pr., GrenobleUniversityHospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC11.210
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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