The management of bipolar mania: a national survey of baseline data from the EMBLEM study in Italy

Background: Although a number of studies have assessed the management of mania in routine clinical practice, no studies have so far evaluated the short- and long- term management and outcome of patients affected by bipolar mania in different European countries. The objective of the study is to present, in the context of a large multicenter survey ( EMBLEM study), an overview of the baseline data on the acute management of a representative sample of manic bipolar patients treated in the Italian psychiatric hospital and community settings. EMBLEM is a 2- year observational longitudinal study that evaluates across 14 European countries the patterns of the drug prescribed in patients with bipolar mania, their socio- demographic and clinical features and the outcomes of the treatment. Methods: The study consists of a 12- week acute phase and a <= 24- month maintenance phase. Bipolar patients were included into the study as in- or out- patients, if they initiated or changed, according to the decision of their psychiatrist, oral antipsychotics, anticonvulsants and/ or lithium for the treatment of an episode of mania. Data concerning socio- demographic characteristics, psychiatric and medical history, severity of mania, prescribed medications, functional status and quality of life were collected at baseline and during the follow- up period. Results: In Italy, 563 patients were recruited in 56 sites: 376 were outpatients and 187 inpatients. The mean age was 45.8 years. The mean CGI- BP was 4.4 ( +/- 0.9) for overall score and mania, 1.9 ( +/- 1.2) for depression and 2.6 ( +/- 1.6) for hallucinations/ delusions. The YMRS showed that 14.4% had a total score < 12, 25.1% >= 12 and < 20, and 60.5% = >= 20. At entry, 75 patients ( 13.7%) were treatment- na ive, 186 ( 34.1%) were receiving a monotherapy ( of which haloperidol [ 24.2%], valproate [ 16.7%] and lithium [ 14.5%] were the most frequently prescribed) while 285 ( 52.2%) a combined therapy ( of which 8.0% were represented by haloperidol/ lithium combinations). After a switch to an oral medication, 137 patients ( 24.8%) were prescribed a monotherapy while the rest ( 415, 75.2%) received a combination of drugs. Conclusion: Data collected at baseline in the Italian cohort of the EMBLEM study represent a relevant source of information to start addressing the short and long- term therapeutic strategies for improving the clinical as well as the socio- economic outcomes of patients affected by bipolar mania. Although it's not an epidemiological investigation and has some limitations, the results show several interesting findings as a relatively late age of onset of bipolar disorder, a low rate of past suicide attempts, a low lifetime rate of alcohol abuse and drug addiction.