Functional impairment in patients with mania: baseline results of the EMBLEM study

Objectives: The European Mania in Bipolar Longitudinal Evaluation of Medication (EMBLEM) is a large-scale prospective observational multicentre study to evaluate the longitudinal course of bipolar disorder and its associations with pharmacological treatment following an acute manic or mixed episode. We present an overview of the study design and patient characteristics at baseline while focusing on factors influencing work performance in the year prior to enrolment. Methods: A total of 530 investigators across 14 European countries enrolled 3,681 patients with acute mania between December 2002 and June 2004. Longitudinal observations are ongoing until July 2006. Socio-demographic variables, psychiatric history, clinical status and information on pharmacological treatment for bipolar disorder were recorded. Items from the SLICE of LIFE were applied, including a measure of work impairment during the previous year. The distribution of the baseline characteristics was analysed with descriptive statistics. Eighteen variables were investigated as hypothesized risk factors for work impairment applying logistic regression models. Results: In the previous year, 28 and 68% of patients were classified as having 'low' and 'high' work impairment, respectively. Clinical Global Impression - Bipolar Disorder (CGI-BP) overall, CGI-BP depression at baseline, rapid cycling during the previous 12 months, age between 35 and 64 years, substance abuse other than alcohol and cannabis and living without a partner or as dependent household member were significantly associated with work impairment during the previous year. Conclusions: EMBLEM is to our knowledge the largest prospective observational study assessing patients during and after an acute episode of mania. Work impairment is significant in the year prior to an acute episode of mania.