SchizophreniaEMOBISCHINCT02841345
Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients
A study testing behavioral and fMRI in people with Schizophrenia and Bipolar Disorder, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- behavioral and fMRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GrenobleUniversityHospital
La Tronche, 38700
MIRCEA POLOSAN, PhD MD Pr., 4 76 76 53 ext. +33 (0), mpolosan@chu-grenoble.fr
AURELIE CAMPAGNE, PhD, 4 56 52 85 08 ext. +33 (0), aurelie.campagne@univ-grenoble-alpes.fr
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- behavioral and fMRI
- Keywords
- emotional processing, action
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral and fMRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar | Other | bipolar patients type I or II (DSM-IV TR), euthymic phase Receives: Other: behavioral and fMRI |
| Schizophrenic | Other | schizophrenic loss or paranoid or undifferentiated patients Receives: Other: behavioral and fMRI |
| Control | Other | control group (paired in age and sex for patients) Receives: Other: behavioral and fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric evaluation
PANSS - POSITIVE AND NEGATIVE SYNDROME SCALE Scale with 30 items
Measured: 70 minutes
Psychometric evaluation
MADRS - Montgomery Asberg Depression Rating
Measured: 15 minutes
Psychometric evaluation
YMRS - Young Mania Rating Scale
Measured: 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
Measured: Few hours
Cognitive questionnaire
CPT II - Conners' Continuous Performance Test II
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startDec 2011
- Primary completion29 Feb 2020 (estimated)
- Study completion29 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AURELIE CAMPAGNE, PhD, Study director, LPNCMIRCEA POLOSAN, PhD MD Pr., Principal investigator, GrenobleUniversityHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841345
- Sponsor's protocol ID
- 38RC11.210
- Acronym
- EMOBISCHI
- Status last verified
- Oct 2018
- First submitted
- 16 Jun 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT02841345
- Acronym / sponsor ID
- EMOBISCHI / 38RC11.210
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- emotional processing, action
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 29 Feb 2020 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar | Other | Other: behavioral and fMRIbipolar patients type I or II (DSM-IV TR), euthymic phase |
| Schizophrenic | Other | Other: behavioral and fMRIschizophrenic loss or paranoid or undifferentiated patients |
| Control | Other | Other: behavioral and fMRIcontrol group (paired in age and sex for patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral and fMRIThe 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 | Bipolar, Control, Schizophrenic |
Primary outcome
Psychometric evaluation
Time frame: 70 minutes
PANSS - POSITIVE AND NEGATIVE SYNDROME SCALE Scale with 30 items
Psychometric evaluation
Time frame: 15 minutes
MADRS - Montgomery Asberg Depression Rating
Psychometric evaluation
Time frame: 15 minutes
YMRS - Young Mania Rating Scale
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
Cognitive questionnaire
Time frame: 15 minutes
CPT II - Conners' Continuous Performance Test II
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AURELIE CAMPAGNE, PhD study director
LPNC
MIRCEA POLOSAN, PhD MD Pr. principal investigator
GrenobleUniversityHospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral and fMRI in people with Schizophrenia and Bipolar Disorder, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VANESSA ESPIN (4 76 76 68 13 ext. +33 (0), VEspin@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric evaluation (time frame: 70 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.