Optimizing Treatment Outcomes in Bipolar Disorder Under Ordinary Conditions
Joseph F. Goldberg, MD
J Clin Psychiatry 2008;69(suppl 3):11-19
© Copyright 2018 Physicians Postgraduate Press, Inc.
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The gold standard for establishing the efficacy of a drug is the
randomized controlled trial (RCT). In the past decade, there has been an
increasing recognition of the important difference between RCTs designed to
demonstrate efficacy and treatment studies designed to evaluate the
effectiveness of various therapies in actual clinical practice. This
distinction is especially true for bipolar disorder, a complex illness whose
treatment response is significantly influenced by various moderating baseline
factors (e.g., comorbidity, severity, treatment resistance) and mediating
factors (e.g., adequacy of dose and treatment duration, use of concomitant
medications, treatment adherence). To reduce sources of variance in treatment
outcome, RCTs rely on restrictive entry criteria in an attempt to control
moderating factors and on highly standardized study procedures in an attempt
to control mediating factors. The goal is to reduce the heterogeneity in the
patient sample and in treatments administered and thereby to increase the
internal validity of the study. Unfortunately, the results of rigorously
controlled RCTs with strong internal validity are often not highly
generalizable to the real-world setting of actual clinical practice. The aim
of this paper is to briefly review key variables that influence treatment
outcome of bipolar disorder in real-world clinical settings and to discuss
strategies for optimizing treatment outcomes under ordinary conditions.