Observational studies on pharmacological treatment for manic episodes and mood stabilization in bipolar disorders

According to the definition of Sackett (1996, BMJ 312: 71–72) evidence based medicine (EBM) is "the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients". However, EBM is not restricted to randomized controlled trials. Instead, a systematic assessment of the tolerability and effectiveness of psychotropic medications following marketing approval (phase IV research) is particularly meaningful when addressing a non-selected population of real-life patients.

Based on these premises, the European observational study EMBLEM (European Mania in Bipolar Longitudinal Evaluation of Medication) is conducted since 2003. The treatment of manic episodes is documented in 14 European countries by 530 physicians for 3536 patients (Germany: 116 physicians/535 patients). Initial results show the long period of time until initiation of an effective therapy by a specialist physician, the importance of suicidality and alcohol consumption as well as a pronounced use of mood stabilizers as combinations (polypharmacy).

The results of the EMBLEM observational study will be complemented by the PROTECT (Prevention of Bipolar Relapse with Olanzapine and Other Mood-Stabilizers) study. The primary objective of PROTECT is to observe the treatment maintenance (maintenance rates, treatment duration) in patients receiving various primary mood stabilizers over a period of 18 months in Germany.