{"doc_desc":{"title":"Etude cas-t\u00e9moins sur l'apathie dans la schizophr\u00e9nie : neuropsychologie et clinique","idno":"FRESH-PEF8593-fr","producers":[{"name":"Richard LEVY","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8593-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8593"},{"agency":"FReSH","code":"FRESH-PEF8593"}]},"title":"Etude cas-t\u00e9moins sur l'apathie dans la schizophr\u00e9nie : neuropsychologie et clinique","alternate_title":"ASCHI"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Richard;LEVY","firstname":"Richard","lastname":"LEVY","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"richard.levy@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"APHP \/ INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), H\u00f4pital de la Piti\u00e9 Salp\u00e9tri\u00e8re","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Richard;LEVY","lastname":"LEVY","firstname":"Richard","type":"contact","email":"richard.levy@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"apathie"},{"keyword":"schizophrenie"}],"topics":[{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Schizophr\u00e9nie","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1683919430","title":"CIM-11"}]},{"topic":"Apathie","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/209677240","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"L'objectif principal est de confirmer que les patients schizophrenes sont apathiques compar\u00e9s \u00e0 des volontaires sains. Les objectifs secondaires sont : - de d\u00e9terminer si l'apathie est li\u00e9e \u00e0 un aspect particulier de la maladie (symptomatologie positive ou n\u00e9gative) - de d\u00e9terminer si l'apathie est corr\u00e9l\u00e9e \u00e0 la dysfonction ex\u00e9cutive - de d\u00e9terminer si l'apathie est associ\u00e9e avec un m\u00e9canisme sp\u00e9cifique, en utilisant une t\u00e2che exp\u00e9rimentale con\u00e7ue sp\u00e9cialement dans le but de caract\u00e9riser diff\u00e9rents m\u00e9canismes ('a-motivation\", \"inertie cognitive\" et \"d\u00e9couplage\") - de d\u00e9terminer s'il y a une anormalit\u00e9 volum\u00e9trique qui affecte le syst\u00e8me ex\u00e9cutif chez les patients schizophr\u00e9niques apathiques - de lier ces \u00e9ventuelles anormalit\u00e9s volum\u00e9triques aux circuits des noyaux gris centraux du cortex pr\u00e9frontal en fonction du sous-type sp\u00e9cifique d'apathie dans le groupe de patients schizophr\u00e9niques apathiques.","abstract":"","coll_dates":[{"start":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Volontaires sains : - homme ou femme - ag\u00e9 de 20 \u00e0 55 ans inclus - couvert par l'assurance maladie  Patients schizophr\u00e8nes :\\n\\n- homme ou femme\\n- \u00e2g\u00e9 de 20 \u00e0 55 ans\\n- couvert par l'assurance maladie\\n- diagnostiqu\u00e9 de schizophr\u00e9nie selon le crit\u00e8re DSM-IV R\\n- dur\u00e9e de la maladie sup\u00e9rieure \u00e0 5 ans\\n- stabilit\u00e9 clinique au cours des deux derniers mois (d\u00e9fini comme absence de modification du traitement ou hospitalisation deux mois avant l'\u00e9valuation)\",\n    \"clusion_E\": \"Volontaires sains : ant\u00e9c\u00e9dents neurologiques  - ant\u00e9c\u00e9dent de traumatisme cr\u00e2nien - abus d'alcool ou de drogues - sous m\u00e9dication psychotrope - pr\u00e9sentant une contre-indication pour une IRM  Patients schizophr\u00e8nes : trouble schizo-affectif - ant\u00e9cedents neurologiques (pass\u00e9 ou pr\u00e9sent) - ant\u00e9c\u00e9dent de traumatisme cr\u00e2nien - abus d'alcool ou de drogues - pr\u00e9sentant une contre-indication pour une IRM\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"12 patients schizophr\u00e8nes; 15 volontaires sains"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"06-06-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Service psychiatrique de l'h\u00f4pital Corentin Celton"},"dataTypes":{"clinicalDataDetails":"Apathie (mesur\u00e9e par l'\u00e9chelle d'\u00e9valuation de l'apathie de Starkstein), performance neuropsychologique: efficiance intellectuelle globale (Mill Hill B, PM 36), fonctions frontales (BREF, MCST, TMT A et B, Stroop, fluences cat\u00e9gorielles), cognition sociale (SEA); m\u00e9moire (Grober et Buschke, empans directs et indirects), fonctions instrumentales (figure de Ray) Symptomatologie positive et negative: PANSS, SANS\/SAPS, Echelle de Calgary, SDS","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}