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Educational Activity

Incorporating Clinical Trial Data Into Bipolar Disorder Management

Terence A. Ketter, MD

Published: July 31, 2008

Article Abstract

Evidence-based medicine integrates data from clinical trials into clinical care while efficacy studies assess simplified interventions in simplified populations. The findings of such studies are useful in obtaining Food and Drug Administration approval of medications but often fail to generalize to the more complex populations and interventions commonly seen in clinical practice. Recently, an increased emphasis has been placed on effectiveness studies (also referred to as pragmatic or practical studies) designed to yield findings that can be generalized to the clinical management of patients with bipolar disorder. Mood stabilizers and increasingly second-generation antipsychotics are considered the foundation of treatment for bipolar disorder. In contrast, adjunctive antidepressants should be avoided when patients present with manic and mixed episodes. Additional interventions—such as psychoeducation and care coordination—when combined with pharmacotherapy, can lessen the frequency and severity of mood episodes, especially mania. These interventions, combined with judicious pharmacotherapy, can help minimize the impact of adverse effects and related nonadherence so that patients can achieve affective stability, regain psychosocial function, and maintain health.

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