Abstract
BACKGROUND: To describe the clinical course and treatment patterns over 24 months of patients experiencing an acute manic/mixed episode within the standard course of care. METHODS: EMBLEM was a 2-year European prospective, observational study on outcomes of patients experiencing a manic/mixed episode. Adults with bipolar disorder were enrolled within the standard course of care as in/outpatients if they initiated or changed oral medication for treatment of acute mania. After completing 12 weeks of acute phase, patients were assessed every 3-6 months during the maintenance phase. We present the 24 month results, with subgroup analysis for mixed states (MS) and pure mania (PM). These subgroup analyses are driven by the high proportion of antidepressants prescribed in this cohort. RESULTS: In France, 771 patients were eligible for the maintenance phase. 69% of patients completed the follow up over 24 months. The mean age was 45.5 years (sd = 13.6) with 57% of women. 504 (66%) patients were experiencing a PM and 262 (34%) a MS at baseline. The main significant differences in MS vs. PM at baseline were: a higher rate of women, and in the previous 12 months, a higher frequency of episodes (manic/mixed and depressive), more suicide attempts, more rapid cycling, fewer social activities and more work impairment. Over the 24 months of follow-up the MS group had a significantly lower recovery than PM (36% vs. 46%, p = 0.006). Overall, 42% of all patients were started on monotherapy and 58% on combination therapy; of those 35% and 30% respectively remained on their initial medication throughout the 24 months. At baseline, 36% were treated with an antidepressant, this proportion remains high throughout the follow-up period, with a significantly higher rate for MS vs. PM at 24 months (55% vs. 27%, p < 0.001). CONCLUSION: In this large sample, MS occur frequently (34%), they are more severe at baseline and have a worse functional prognosis than PM. Although antidepressants are not recommended in MS and PM, they were frequently prescribed at baseline and are maintained during the 24 months of follow-up.