Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-04 @ 8:57 AM
Study NCT ID:
NCT02547259
Status:
COMPLETED
Last Update Posted:
2015-09-11
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Emotion in a Test Run Forgetfulness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-09', 'studyFirstSubmitDate': '2015-09-09', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retained words', 'timeFrame': 'Day 1', 'description': 'Number of selected words and average time taken to recognize between healthy volunteers and schizophrenics (composite measure)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'memory', 'pain'], 'conditions': ['Schizophrenia', 'Healthy Volunteer']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'The study is to go 1 time in hospital for memory test. These tests consist in:\n\n* 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.\n* 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.\n\n 15 schizophrenic will be included in group 1 and 15 other schizophrenics in group 2.\n\n 15 Healthy volunteer will be included in group 1 and 15 other Healthy volunteer in group 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients:\n* schizophrenic age 18 years to 55 years\n* Stabilized, clinical and therapeutic point of view, since at least one month.\n* Good knowledge of French\n* Healthy volunteer\n* age 18 years to 55 years\n* Good knowledge of French\n* Matching on age (± 5 years) and level of study patients\n\nExclusion Criteria:\n\n* Patients\n* History of head trauma, neurological disease with cerebral repercussion or not stabilized or serious physical illness causing pain\\> 3 months.\n* Recent Amendment of psychotropic therapy (\\<1 month)\n* Consumption of benzodiazepines long-term (negative effect on memory capacity)\n* Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal).\n* Healthy volunteer\n* Consumption of benzodiazepines long-term (negative effect on memory capacity)\n* Troubles Related to the use of a psychoactive substance, as defined by the DSM IV (recent use, abuse, dependence or withdrawal).'}, 'identificationModule': {'nctId': 'NCT02547259', 'briefTitle': 'Influence of Emotion in a Test Run Forgetfulness', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Influence of Negative or Painful Emotions in a Directed Forgetting Paradigm in Healthy Subjects and Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '1108067'}, 'secondaryIdInfos': [{'id': '2011-A00582-39', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'schizophrenic pain words test', 'description': 'schizophrenic will have memory test with pain words on computer', 'interventionNames': ['Procedure: pain words test']}, {'type': 'EXPERIMENTAL', 'label': 'schizophrenic negative words test', 'description': 'schizophrenic will have memory test with negative words on computer', 'interventionNames': ['Procedure: negative words test']}, {'type': 'OTHER', 'label': 'Healthy volunteer pain words test', 'description': 'Healthy volunteer will have memory test with pain words on computer', 'interventionNames': ['Procedure: pain words test']}, {'type': 'OTHER', 'label': 'Healthy volunteer negative words test', 'description': 'Healthy volunteer will have memory test with negative words on computer', 'interventionNames': ['Procedure: negative words test']}], 'interventions': [{'name': 'pain words test', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Healthy volunteer pain words test', 'schizophrenic pain words test']}, {'name': 'negative words test', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Healthy volunteer negative words test', 'schizophrenic negative words test']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catherine MASSOUBRE, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}