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The ECNP Consensus Statement on Bipolar Depression BARCELONA, Spain -- September 3, 2008 -- The following consensus statement of the the European College of Neuropsychopharmacology on Bipolar Depression was presented at the 21st Congress of the European College of Neuropsychopharmacology 2008 in Barcelona, Spain. Bipolar disorder is one of the most important psychiatric diseases, often associated with considerable treatment needs and tremendous social and occupational burden for both the individual and family. Bipolar I disorder is characterised by a history of at least 1 manic episode, with or without depressive symptoms. Bipolar II disorder is characterised by the presence of both depressive symptoms and a less severe form of mania (hypomania). Clinical decisions pertaining to the treatment of bipolar disorder essentially are grouped around the topics of depression, mania, and rapid cycling/mixed states. Treatment Studies in Bipolar Depression Monotherapy trials against placebo remain the gold-standard design for determining efficacy in bipolar depression. If efficacy happens to be proven as monotherapy, new compounds may be tested in adjunctive-medication placebo-controlled trials. Younger adults, without an established need for long-term medication, may be particularly suitable for clinical trials requiring placebo-controls. Switch to mania or hypomania may be the consequence of active treatment for bipolar depression. Some medications such as the tricyclic antidepressants and venlafaxine may be more likely to provoke switch than others, but this increased rate of switch may not be seen until about 10 weeks of treatment. Thus, 12-week trials against placebo are necessary to determine the risk of switch and to establish continuing effects. Careful assessments at 6 to 8 weeks are required to ensure that patients who are failing to respond do not continue in a study for unacceptable periods of time. Switching from bipolar depression to mania or hypomania is the particular risk that requires a different approach to treatment from unipolar depression. Long-Term Treatment Long-term treatment is commonly required in bipolar disorder. Thus, trials to detect maintenance of effect or continued response in bipolar depression should follow a relapse prevention design: ie, patients are treated in an episode with the medicine of interest and then randomised to either continue the active treatment or placebo. However, acute withdrawal of active medication after treatment response might artificially enhance effect size due to active drug withdrawal effects. Thus, long periods of mood stabilisation for up to 3 months may appear desirable, but protocol compliance may then be difficult to achieve in practice and certainly will make studies more difficult and expensive to conduct. The addition of a medicine to other agents during or after the resolution of a depressive or manic episode, and its subsequent investigation as monotherapy against placebo to prevent further relapse also is clinically informative. Finally, besides the traditional measures of outcome based on symptom severity rating scales, it would be advisable to include measures addressing functionality, such as neuropsychological tests of attention, memory, executive function, and quality of life. Long-term prevention of relapse is the major challenge in bipolar disorder. Success requires a mature therapeutic alliance between doctor and patient, effective self-management by the patients and their families, and effective, well-tolerated treatments. Bipolar Depression: A Major Treatment Challenge Bipolar disorder may be defined by the existence of depression and hypomania, but its long-term course is almost always dominated by depressive rather than hypomanic symptoms. Patients with bipolar disorders are at a substantially increased risk of suicide, particularly during depressive episodes. Furthermore, in bipolar patients a high degree of concurrent and sequential comorbidity with other mental disorders and physical illnesses is common. Unfortunately, all too often patients with bipolar disorders remain unrecognised by health professionals, untreated, or improperly treated, which clearly is associated with a lower life expectancy, a more malignant course, and an altogether lower quality of life. In particular bipolar II disorder has been under-recognized until recently, in part owing to difficulties in distinguishing bipolar from unipolar depression. Thus, a major challenge in the treatment of patients with mood disorders is the distinction between bipolar and unipolar depression, since these mood disorders require different approaches to treatments. There is a considerable longitudinal risk -- probably over 10% -- that initial unipolar depressive patients ultimately turn out as bipolar patients in the longer run. Bipolar Depression in Children Bipolar disorder exists in children and adolescents, but the age at which bipolar disorder can first be diagnosed remains controversial. Although bipolar-like symptoms may be quite frequent, reliably defined bipolar I disorder is rare in prepubertal children. Since early intervention may improve diagnosis, treatment studies are an important objective for future research. The need for an increased capacity to conduct reliable trials in children and adolescents is a challenge to Europe. The ECNP supports collaborating networks of clinicians in Europe who seek to improve treatment and research in children and in bipolar disorder. Epidemiology Recent studies have suggested that bipolar disorders are much more frequent than previously thought. Almost 2% of the European Union population is, or will be, suffering from bipolar disorders in the course of their lives. When the wider range of the bipolar spectrum of conditions is considered, estimates might be increased to as much as 6%. The first onset of bipolar disorders tends to be earlier than that of unipolar major depression in population samples, which may indicate that bipolar disorders have partly different causal factors promoting the illness. The risk for this illness is highest in the time period between late adolescence and the third decade and is substantially decreased after this age; conversely, the overall the risk of unipolar major depression continues to grow further on into old age. A consequence of the symptoms of bipolar disorder is that patients experience a debilitating decrease in functioning not only during their acute stages of illness, but increasingly also in between episodes. The early onset of bipolar disorder potentially implies a severe burden of disease in terms of impaired social and neuropsychological development, most of which is attributable to the acute depression episodes. SOURCE: European College of Neuropsychopharmacology E-mail this page to a friend or colleague! To print, use this version