{"doc_desc":{"title":"Cohort of Patients with Depression: Toxic Effects on Brain Function","idno":"FRESH-PEF4545-en","producers":[{"name":"Bruno FALISSARD","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF4545-en","IDno":{"metadata_no":[{"agency":"PEF","code":"4545"},{"agency":"FReSH","code":"FRESH-PEF4545"}]},"title":"Cohort of Patients with Depression: Toxic Effects on Brain Function","alternate_title":""},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Bruno;FALISSARD","PILabo":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE \/ Inserm U1018 \u2013 Centre for Research in Epidemiology and Population Health \u2013 Team: Gender, Sexual and Reproductive Health","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-2418-4954","role":"pi id"},{"title":"IdRef","uri":"034648739","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"bruno.falissard@universite-paris-saclay.fr","isContact":"Yes"},{"type":"investigator","name":"Emmanuelle;CORRUBLE","PILabo":"INSERM \u2013 National Institute of Health and Medical Research \/ INSERM U669 BICETRE UNIVERSITY HOSPITAL \u2013 PSYCHIATRIC DEPARTMENT","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-4481-9494","role":"pi id"},{"title":"IdRef","uri":"050310674","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"emmanuelle.corruble@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":"ASTRAZENECA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016qv5070"},{"title":"SIREN","uri":"558201075"}]},{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]},{"name":"EISAI SAS","extlink":[{"title":"SIREN","uri":"403459639"}]},{"name":"JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)","extlink":[{"title":"SIREN","uri":"562033068"}]},{"name":"LES LABORATOIRES SERVIER","extlink":[{"title":"SIREN","uri":"085480796"}]},{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153"}]},{"name":"LUNDBECK SAS","extlink":[{"title":"SIREN","uri":"552123200"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]},{"name":"PIERRE FABRE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04hdhz511"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]},{"name":"UCB PHARMA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01n6t9x28"},{"title":"SIREN","uri":"562079046"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Bruno;FALISSARD","email":"bruno.falissard@universite-paris-saclay.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"Emmanuelle;CORRUBLE","email":"emmanuelle.corruble@aphp.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"large sample"},{"keyword":"outpatient"},{"keyword":"treatment time"},{"keyword":"toxic effects"},{"keyword":"brain function"},{"keyword":"tests"}],"topics":[{"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"}]}],"purpose":"To assess the impact of depression on the hippocampus.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"Outpatients from selected physicians who: \u2013 meet the DSM-IV criteria for major depressive disorder based on clinical assessment criteria;  \u2013 were tested for delayed memory function during two visits several weeks apart.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"8,229"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort 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":"22-10-2012","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2018","isContributorPI":"No","contributorName":"Bruno FALISSARD","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Publication PubMed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Toxic+effects+of+depression+on+brain+function%3A+impairment+of+delayed+recall+and+the+cumulative+length+of+depressive+disorder+in+a+large+sample+of+depressed+outpatients."}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry","Industry","Industry","Industry","Industry","Industry","Industry","Industry","Industry","Industry","Other"],"otherFundingAgentType":["","","","","","","","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: Hospital Anxiety and Depression Scale.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Anxiety and depression (Hospital Anxiety and Depression Scale), previous depressive episodes; treatment or non-treatment with antidepressants; previous mood disorders; Wechsler Memory Scale memory test (marker of hippocampal function).","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"}