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Influence of Emotion in a Test Run Forgetfulness

Primary Purpose

Schizophrenia, Healthy Volunteer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pain words test
negative words test
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring schizophrenia, memory, pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients:
  • schizophrenic age 18 years to 55 years
  • Stabilized, clinical and therapeutic point of view, since at least one month.
  • Good knowledge of French
  • Healthy volunteer
  • age 18 years to 55 years
  • Good knowledge of French
  • Matching on age (± 5 years) and level of study patients

Exclusion Criteria:

  • Patients
  • History of head trauma, neurological disease with cerebral repercussion or not stabilized or serious physical illness causing pain> 3 months.
  • Recent Amendment of psychotropic therapy (<1 month)
  • Consumption of benzodiazepines long-term (negative effect on memory capacity)
  • Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal).
  • Healthy volunteer
  • Consumption of benzodiazepines long-term (negative effect on memory capacity)
  • Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Other

    Other

    Arm Label

    schizophrenic pain words test

    schizophrenic negative words test

    Healthy volunteer pain words test

    Healthy volunteer negative words test

    Arm Description

    schizophrenic will have memory test with pain words on computer

    schizophrenic will have memory test with negative words on computer

    Healthy volunteer will have memory test with pain words on computer

    Healthy volunteer will have memory test with negative words on computer

    Outcomes

    Primary Outcome Measures

    Retained words
    Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2015
    Last Updated
    September 9, 2015
    Sponsor
    Centre Hospitalier Universitaire de Saint Etienne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02547259
    Brief Title
    Influence of Emotion in a Test Run Forgetfulness
    Official Title
    Influence of Negative or Painful Emotions in a Directed Forgetting Paradigm in Healthy Subjects and Patients With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Saint Etienne

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Currently there is uncertainty on how schizophrenic patients feel pain. Pain has several components including cognitive behavior which allow humans to perceive it as a negative emotion. It is difficult to say precisely what are the differences in cognitive processing between the emotional component of pain and painless another negative emotion (eg fear). However, pain and negative emotion have some neural networks together and there are many common ways between emotional processing (pain or negative) and storing information (limbic system).
    Detailed Description
    The study is to go 1 time in hospital for memory test. These tests consist in: Group 1: words to painful sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer will need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word. Group 2: words to negative sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word. 15 schizophrenic will be included in group 1 and 15 other schizophrenics in group 2. 15 Healthy volunteer will be included in group 1 and 15 other Healthy volunteer in group 2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Healthy Volunteer
    Keywords
    schizophrenia, memory, pain

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    schizophrenic pain words test
    Arm Type
    Experimental
    Arm Description
    schizophrenic will have memory test with pain words on computer
    Arm Title
    schizophrenic negative words test
    Arm Type
    Experimental
    Arm Description
    schizophrenic will have memory test with negative words on computer
    Arm Title
    Healthy volunteer pain words test
    Arm Type
    Other
    Arm Description
    Healthy volunteer will have memory test with pain words on computer
    Arm Title
    Healthy volunteer negative words test
    Arm Type
    Other
    Arm Description
    Healthy volunteer will have memory test with negative words on computer
    Intervention Type
    Procedure
    Intervention Name(s)
    pain words test
    Intervention Description
    words to painful sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer will need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
    Intervention Type
    Procedure
    Intervention Name(s)
    negative words test
    Intervention Description
    words to negative sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the "D" key on the keyboard if they feel that they have not learned this word.
    Primary Outcome Measure Information:
    Title
    Retained words
    Description
    Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients: schizophrenic age 18 years to 55 years Stabilized, clinical and therapeutic point of view, since at least one month. Good knowledge of French Healthy volunteer age 18 years to 55 years Good knowledge of French Matching on age (± 5 years) and level of study patients Exclusion Criteria: Patients History of head trauma, neurological disease with cerebral repercussion or not stabilized or serious physical illness causing pain> 3 months. Recent Amendment of psychotropic therapy (<1 month) Consumption of benzodiazepines long-term (negative effect on memory capacity) Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal). Healthy volunteer Consumption of benzodiazepines long-term (negative effect on memory capacity) Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine MASSOUBRE, MD-PhD
    Organizational Affiliation
    CHU SAINT-ETIENNE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Influence of Emotion in a Test Run Forgetfulness

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