The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study.

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.

The inland water macro-invertebrate occurrences in Flanders, Belgium.

The Flanders Environment Agency (VMM) has been performing biological water quality assessments on inland waters in Flanders (Belgium) since 1989 and sediment quality assessments since 2000. The water quality monitoring network is a combined physico-chemical and biological network, the biological component focusing on macro-invertebrates. The sediment monitoring programme produces biological data to assess the sediment quality. Both monitoring programmes aim to provide index values, applying a similar conceptual methodology based on the presence of macro-invertebrates. The biological data obtained from both monitoring networks are consolidated in the VMM macro-invertebrates database and include identifications at family and genus level of the freshwater phyla Coelenterata, Platyhelminthes, Annelida, Mollusca, and Arthropoda. This paper discusses the content of this database, and the dataset published thereof: 282,309 records of 210 observed taxa from 4,140 monitoring sites located on 657 different water bodies, collected during 22,663 events. This paper provides some background information on the methodology, temporal and spatial coverage, and taxonomy, and describes the content of the dataset. The data are distributed as open data under the Creative Commons CC-BY license.