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Evolving methodologies in bipolar disorder maintenance research

  • Joseph R. Calabrese (a1), Daniel J. Rapport (a1), Melvin D. Shelton (a1) and Susan E. Kimmel (a1)
Abstract
Background

During the development of a new treatment for bipolar disorder, maintenance studies are used to evaluate the ability of the putative mood stabiliser to prevent relapse and recurrence of further episodes. Comparisons with the early bipolar disorder maintenance studies indicate that the methodologies of recent trials have evolved substantially.

Aims

To review the methods used in the first- and second-generation maintenance studies, highlighting the differences of the various designs.

Method

Literature review.

Results

Methods that have evolved the most include patient enrolment, randomisation schemes and the use of outcome measures and statistical analyses. In addition, regulatory and commercial issues have also influenced study design.

Conclusion

There is little consensus on the methodology of bipolar disorder maintenance studies. As the integration of newer therapies into routine clinical practice is dependent on the evidence from controlled studies, it is essential that future maintenance trials in bipolar disorder achieve adequate methodological rigour without sacrificing overall feasibility.

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Copyright
Corresponding author
Dr Joseph R. Calabrese, Mood Disorders Program, Department of Psychiatry, Case Western Reserve University, School of Medicine, 10900 Euclid Avenue, Cleveland, OH 44106, USA. Tel: +1 216 844 2850; fax: +1 216 844 2875; e-mail: jrc8@po.cwru.edu
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Declaration of interest

Funding and consultation fees (detailed in Acknowledgements) received from various sources, including the pharmaceutical industry.

Footnotes
References
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Evolving methodologies in bipolar disorder maintenance research

  • Joseph R. Calabrese (a1), Daniel J. Rapport (a1), Melvin D. Shelton (a1) and Susan E. Kimmel (a1)
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