{"doc_desc":{"title":"Apathy in Schizophrenia: A Case-Control Clinical and Neuropsychological Study","idno":"FRESH-PEF8593-en","producers":[{"name":"Richard LEVY","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8593-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8593"},{"agency":"FReSH","code":"FRESH-PEF8593"}]},"title":"Apathy in Schizophrenia: A Case-Control Clinical and Neuropsychological Study","alternate_title":"ASCHI"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Richard;LEVY","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","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"072798599","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"richard.levy@aphp.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"richard.levy@aphp.fr","type":"contact","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":"apathy"},{"keyword":"schizophrenia"}],"topics":[{"topic":"Neurology","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":"Psychiatry","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":"Schizophrenia","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1683919430","title":"CIM-11"}]},{"topic":"Apathy","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/209677240","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"The main objective is to confirm that schizophrenic patients are apathetic compared to health volunteers. Secondary objectives: - to investigate if apathy is related to a particular aspect of the disease (i.e., negative or positive symptomatology); - to investigate if apathy correlates with executive dysfunction; - to investigate if apathy is associated with a specific mechanism using an experimental task specially designed to characterise different mechanisms (i.e., \"a-motivation\", \"cognitive inertia\", and \"uncoupling\"); - to investigate if there is a volumetric abnormality affecting the executive system in apathetic schizophrenic patients; - to link these possible volumetric abnormalities to the prefrontal cortex-basal ganglia circuits according to a specific apathy subtype within the apathetic schizophrenic group.","abstract":"","coll_dates":[{"start":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Healthy volunteers: -Male or female; -Aged 20 to 55; -With health insurance.  Schizophrenia patients:\\n-Male or female\\n-Aged 20 to 55\\n-With health insurance\\n-Daignosed as schizophrenic according to DSM-IV R criteria\\n-Illness with a duration of over 5 years\\n-Clinical stability during the past 2 months (defined as no treatment modification or hospitalisation 2 months prior to evaluation).\",\n    \"clusion_E\": \"Healthy volunteers: History of neurological disorder; -Previous head injury; -Alcohol or substance abuse; -On psychotropic medication; -Contraindication to MRI.Schizophrenia patients: Schizo-affective disorder; -History of neurological disorders (past or present); -Previous head injury; -Alcohol or substance abuse; -Contraindication to MRI.\"\n}","data_kind":"['Clinical data','Paraclinical data (non-biological) : Anthropometry']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"12 schizophrenic patients; 15 healthy volunteers."},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Case-control study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"06-06-2014","isContributorPI":"No","contributorName":"Richard LEVY","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","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":"No","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":"No"},"geographicalCoverage":{"geoDetail":"Psychiatric department in Corentin Celton Hospital"},"dataTypes":{"clinicalDataDetails":"Apathy (measured by Starkstein's Apathy Evaluation Scale), neuropsychological performance: global mental efficience (Mill Hill B, PM 38), frontal assessments (BREF, MCST, TMT A and B, Stroop, verbal fluences), social cognition (SEA); memory (Grober and Buschke, direct-indirect digit span), instrumental functions: Rey figure), positive and negative symptomatology: PANSS, SANS\/SAPS, Calgary Scale, SDS.","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}