Abstract
EMBLEM is a prospective, multicenter observational study on the management of patients with a manic or mixed episode in routine clinical practice (total of 3566 subjects included in 14 European countries). The study consisted of a 12-week acute phase and a 24-month maintenance phase. Subjects were included if they initiated or changed oral medication, according to the decision of the treating psychiatrist, with antipsychotics, anticonvulsants and / or lithium, for the treatment of a manic or mixed episode. The present report describes the acute phase outcomes of the French subgroup. Between December 2002 and June 2004, 126 investigators included a total of 795 subjects as in- or outpatients (450 women, 320 men, mean age: 45.6 years). The episode was most often recurrent (74.7 %) and patients were suffering from either a manic (65.8 %) or a mixed episode (34.2 % vs. EMBLEM Europe, 24 %). The intensity of manic symptoms was elevated (YMRS mean total score: 26.6) and functional impairment of the individuals was high, with 41.9 % experiencing moderate to severe work impairment and 23.6 % being unable to work. The prevalence of suicide attempts was 35.8 % (lifelong), close to the prevalence in the other French cohort EPIMAN (32 %). Abuse / dependence on alcohol and cannabis were present in 10.2 % and 11.1 % of subjects, respectively. At entry, 37.4 % were receiving monotherapy while 27.3 % received a combined therapy. All patients received treatment for their manic / mixed episode, either in combination (59.2 %) or in monotherapy (40.8 %). Atypical antipsychotics were more often prescribed in association (34.0 % of subjects) than in monotherapy (21.1 %). In patients treated in monotherapy, atypical antipsychotics were the most often prescribed drug (51.9 %). Results showed an improvement within both monotherapy and combination therapy in effectiveness measures at week 12. After 12 weeks, 31.3 % were considered recovered and 67.9 % did not relapse. These results confirm current data on co-morbidities and give information on treatment for bipolar patients at three months of follow-up. The long-term evaluation of the French EMBLEM cohort - 12, 24 months and up to five years - is presently ongoing.
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