{"doc_desc":{"title":"Etude longitudinale sur des patients adultes pr\u00e9sentant un \u00e9pisode d\u00e9pressif majeur d\u00e9butant un traitement par antid\u00e9presseur consultant en psychiatrie lib\u00e9rale","idno":"FRESH-PEF183-fr","producers":[{"name":"Christine TRUCHI","affiliation":"LUNDBECK SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF183-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"183"},{"agency":"FReSH","code":"FRESH-PEF183"}]},"title":"Etude longitudinale sur des patients adultes pr\u00e9sentant un \u00e9pisode d\u00e9pressif majeur d\u00e9butant un traitement par antid\u00e9presseur consultant en psychiatrie lib\u00e9rale","alternate_title":"SurPass"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Anne;CROCHARD","firstname":"Anne","lastname":"CROCHARD","type":"investigator","extlink":[{"title":"SIREN","uri":"552123200","role":"organisation id"}],"email":"","affiliationName":"LUNDBECK SAS","PILabo":"Lundbeck \/ Lundbeck","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LUNDBECK SAS","extlink":[{"title":"SIREN","uri":"552123200","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"LUNDBECK SAS","extlink":[{"title":"SIREN","uri":"552123200"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"retentissement fonctionnel"},{"keyword":"antid\u00e9presseur"},{"keyword":"psychiatrie"}],"topics":[{"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":"Recours aux serices de sant\u00e9 pour procr\u00e9ation m\u00e9dicalement assist\u00e9e","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/299316821","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Etablir la typologie de patients souffrant d\u2019un \u00e9pisode d\u00e9pressif majeur caract\u00e9ris\u00e9, trait\u00e9s par antid\u00e9presseur et suivis en psychiatrie lib\u00e9rale, selon leur profil \u00e9volutif \u00e0 6 mois et identifier les facteurs pr\u00e9dictifs d\u2019une \u00e9volution du retentissement de leur maladie dans les sph\u00e8res sociale, familiale et professionnelle.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patient \u00e2g\u00e9 de 18 ans et plus, pr\u00e9sentant un \u00e9pisode d\u00e9pressif majeur selon le DSM-IV, d\u00e9butant un traitement par antid\u00e9presseur, consultant en psychiatrie lib\u00e9rale ; Patient pouvant \u00eatre suivi 6 mois ; Patient pouvant communiquer et s\u2019auto-\u00e9valuer\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","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\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Tests psychologiques\/\u00e9chelles cliniques (d\u00e9pression, cognition, qualit\u00e9 de vie...)\"}","{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\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":"[1000-10000[ individus","response_rate":"4 300"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"","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":"16-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"11-02-2014","isContributorPI":false,"contributorName":"Christine TRUCHI","contributorAffiliation":"LUNDBECK SAS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les donn\u00e9es sont recueillies \u00e0 l\u2019occasion de visites spontan\u00e9es des patients \u00e0 l\u2019inclusion puis \u00e0 environ 2 et 6 mois. Les donn\u00e9es recueillies lors de chacune de ces visites consisteront notamment en une \u00e9chelle de Sheehan aux visites d\u2019inclusion et \u00e0 6 mois, qui sont compl\u00e9t\u00e9es par le patient et une \u00e9chelle MADRS (s\u00e9v\u00e9rit\u00e9 de la d\u00e9pression) compl\u00e9t\u00e9e par l\u2019investigateur. Les patients r\u00e9pondant aux crit\u00e8res d\u2019\u00e9ligibilit\u00e9 et non inclus dans l\u2019\u00e9tude sont renseign\u00e9s dans un registre de non inclusion qui permettra de v\u00e9rifier la repr\u00e9sentativit\u00e9 de la population incluse dans l\u2019\u00e9tude. Ce registre est \u00e0 compl\u00e9ter jusqu\u2019\u00e0 inclusion effective de 4 \u00e0 5 patients dans la cohorte.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","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"}