NCT02841345

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

8.3 years

First QC Date

June 16, 2016

Last Update Submit

October 10, 2018

Conditions

Keywords

emotional processingaction

Outcome Measures

Primary Outcomes (5)

  • Psychometric evaluation

    PANSS - POSITIVE AND NEGATIVE SYNDROME SCALE Scale with 30 items

    70 minutes

  • Psychometric evaluation

    MADRS - Montgomery Asberg Depression Rating

    15 minutes

  • Psychometric evaluation

    YMRS - Young Mania Rating Scale

    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

    Few hours

  • Cognitive questionnaire

    CPT II - Conners' Continuous Performance Test II

    15 minutes

Study Arms (3)

Bipolar

OTHER

bipolar patients type I or II (DSM-IV TR), euthymic phase

Other: behavioral and fMRI

Schizophrenic

OTHER

schizophrenic loss or paranoid or undifferentiated patients

Other: behavioral and fMRI

Control

OTHER

control group (paired in age and sex for patients)

Other: behavioral and fMRI

Interventions

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.

BipolarControlSchizophrenic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Informed Consent signed
  • Membership or beneficiary of a social security scheme
  • Age over 18 years
  • Language and French culture
  • study BAC level or equivalent
  • +36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GrenobleUniversityHospital

La Tronche, 38700, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • AURELIE CAMPAGNE, PhD

    LPNC

    STUDY DIRECTOR
  • MIRCEA POLOSAN, PhD MD Pr.

    GrenobleUniversityHospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 22, 2016

Study Start

December 1, 2011

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations