- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02547259
Influence of Emotion in a Test Run Forgetfulness
Influence of Negative or Painful Emotions in a Directed Forgetting Paradigm in Healthy Subjects and Patients With Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: schizophrenic pain words test
schizophrenic will have memory test with pain words on computer
|
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.
|
|
Experimental: schizophrenic negative words test
schizophrenic will have memory test with negative words on computer
|
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.
|
|
Other: Healthy volunteer pain words test
Healthy volunteer will have memory test with pain words on computer
|
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.
|
|
Other: Healthy volunteer negative words test
Healthy volunteer will have memory test with negative words on computer
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retained words
Time Frame: Day 1
|
Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine MASSOUBRE, MD-PhD, CHU Saint-Etienne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
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
- 1108067
- 2011-A00582-39 (Other Identifier: AFSSAPS)
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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