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17 - Investigational strategies: treatment of rapid cycling, mixed episodes, and atypical bipolar mood disorder

Published online by Cambridge University Press:  10 August 2009

By
Gary Sachs  and
Mandy Graves
Edited by
Andreas Marneros  and
Frederick Goodwin
Gary Sachs
Affiliation:
Massachusetts General Hospital Partners Bipolar Treatment Center Boston, MA USA
Mandy Graves
Affiliation:
Massachusetts General Hospital Partners Bipolar Treatment Center Boston, MA USA
Andreas Marneros
Affiliation:
Martin Luther-Universität Halle-Wittenburg, Germany
Frederick Goodwin
Affiliation:
George Washington University, Washington DC
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Summary

The psychiatric literature includes relatively few adequately powered controlled double-blind clinical trials reporting results for bipolar disorders. The majority of these randomized clinical trials report results for treatment of acute mania in hospitalized bipolar I (BP-I) patients. The majority of bipolar patients are, however, not BP-I and manic states are relatively infrequent. Why are there so few published controlled treatment studies dealing with common clinical problems like rapid cycling, mixed episodes, and atypical bipolar disorder?

Rapid cycling, mixed episodes, and atypical bipolar mood disorder each challenge clinical researchers in distinctly different ways. This chapter explores the issues as they relate to study design in general and offers suggestions for study methodology.

The first consideration is the conceptual dissimilarity of the terms rapid cycling, mixed episodes, and atypical bipolar disorder. These terms correspond to three distinct organizational levels used in the Diagnostic and Statistical Manual of Mental Disorders, 4th edn (DSM-IV) mood-disorder nosology and represent the concepts of course specifier, acute episode, and subtype of bipolar (American Psychiatric Association, 1994). Study designs for each require attention to sample selection, outcome measures, and an analysis plan matched to the appropriate level in the organizational hierarchy of the DSM-IV mood-disorder classification.

Difficulties in conducting clinical trials for atypical bipolar disorder

The DSM-IV bipolar mood disorder category is subtyped into BP-I, BP-II, cyclothymia, and bipolar disorder not otherwise specified. The latter encompasses all forms of “atypical bipolar disorder” which do not meet criteria for one of the three defined subtypes.

Keywords

atypical bipolar mood disorderclinical trialsdepressionDSM IVrapid-cycling patientsmaniamixed episodes
Type
Chapter
Information
Bipolar Disorders
Mixed States, Rapid Cycling and Atypical Forms
 , pp. 369 - 385
Publisher: Cambridge University Press
Print publication year: 2005

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