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
About this trial
This is an interventional diagnostic trial for Schizophrenia focused on measuring schizophrenia, memory, pain
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).
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
NCT ID
NCT02547259
First Posted
September 9, 2015
Last Updated
September 9, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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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