The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study
| dc.rights.license | open | en_US |
| dc.contributor.author | GORWOOD, P. | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | BENICHOU, Jacques | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | MOORE, Nicholas | |
| dc.contributor.author | ALVAREZ MARTINEZ, E. | |
| dc.contributor.author | MERTENS, J. | |
| dc.contributor.author | AGUGLIA, E. | |
| dc.contributor.author | FIGUEIRA, M. L. | |
| dc.contributor.author | FALKAI, P. | |
| dc.contributor.author | OLIVIER, V. | |
| dc.contributor.author | WATTEZ, M. | |
| dc.contributor.author | PICAREL-BLANCHOT, F. | |
| dc.contributor.author | DE BODINAT, C. | |
| dc.date.accessioned | 2021-03-22T14:23:03Z | |
| dc.date.available | 2021-03-22T14:23:03Z | |
| dc.date.issued | 2020-09-25 | |
| dc.identifier.issn | 1099-1077 (Electronic) 0885-6222 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/26777 | |
| dc.description.abstractEn | OBJECTIVE: The present observational cohort study documented the safety of agomelatine in current medical practice in out-patients suffering from major depressive disorder. METHOD: The 6-month evolution of agomelatine-treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI-S) score, and functioning measured by the Sheehan Disability Scale (SDS). RESULTS: A total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.7%; mean age: 49.1 ± 14.8 years). Adverse events reported were in accordance with the known safety profile of agomelatine. Cutaneous events were reported in 1.7% of the patients and increased hepatic transaminases values were reported in 0.9 % of the patients. The incidence of events related to suicide/self-injury was 1.0%. Two completed suicides, not related to the study drug, were reported. CGI-S total scores and SDS sub-scores improved and numbers of days lost or underproductive decreased over the treatment period. CONCLUSIONS: In standard medical practice, agomelatine treatment was associated with a low incidence of side effects. No unexpected events were reported. A decrease in the severity of the depressive episode and improved functioning were observed. TRIAL REGISTRATION NAME: Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients. A prospective, observational (non-interventional), international, multicentre cohort study. TRIAL REGISTRATION NUMBER: ISRCTN53570733. | |
| dc.language.iso | EN | en_US |
| dc.rights | Attribution 3.0 United States | * |
| dc.rights.uri | http://creativecommons.org/licenses/by/3.0/us/ | * |
| dc.title.en | The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study | |
| dc.title.alternative | Hum Psychopharmacol | en_US |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1002/hup.2759 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 32976677 | en_US |
| bordeaux.journal | Human Psychopharmacology: Clinical and Experimental | en_US |
| bordeaux.page | e2759 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - U1219 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.team | PharmacoEpi-Drugs | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.export | false | |
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