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REVIEW ARTICLE

The World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Biological Treatment of Bipolar Disorders: Update 2012 on the long-term treatment of bipolar disorder

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Pages 154-219 | Received 22 Jan 2013, Accepted 23 Jan 2013, Published online: 13 Mar 2013
 

Abstract

Objectives. These guidelines are based on a first edition that was published in 2004, and have been edited and updated with the available scientific evidence up to October 2012. Their purpose is to supply a systematic overview of all scientific evidence pertaining to the long-term treatment of bipolar disorder in adults. Methods. Material used for these guidelines are based on a systematic literature search using various data bases. Their scientific rigor was categorised into six levels of evidence (A–F) and different grades of recommendation to ensure practicability were assigned. Results. Maintenance trial designs are complex and changed fundamentally over time; thus, it is not possible to give an overall recommendation for long-term treatment. Different scenarios have to be examined separately: Prevention of mania, depression, or an episode of any polarity, both in acute responders and in patients treated de novo. Treatment might differ in Bipolar II patients or Rapid cyclers, as well as in special subpopulations. We identified several medications preventive against new manic episodes, whereas the current state of research into the prevention of new depressive episodes is less satisfactory. Lithium continues to be the substance with the broadest base of evidence across treatment scenarios. Conclusions. Although major advances have been made since the first edition of this guideline in 2004, there are still areas of uncertainty, especially the prevention of depressive episodes and optimal long-term treatment of Bipolar II patients.

Acknowledgements

We would like to specially thank Dr Andrea King and Mrs Reetta Karjalainen, WFSBP office Vienna, for general and editorial assistance.

Statement of Interest of principal authors

Heinz Grunze received grants/research support, consulting fees and honoraria within the last three years from Astra Zeneca, BMS, Desitin, Eli Lilly, Gedeon-Richter, Hoffmann-LaRoche, Janssen-Cilag, Lundbeck, Merck, Otsuka, Sanofi-Aventis, Servier, Sepracor, and UBC.

Eduard Vieta received grants/research support, consulting fees and honoraria within the last three years from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Forest Research Institute, Gedeon Richter, Glaxo-Smith-Kline, Janssen, Jazz, Johnson & Johnson, Lundbeck, Merck-Sharp and Dohme, Novartis, Otsuka, Pfizer Inc, Roche Sanofi-Aventis, Servier, Shering-Plough, Solvay, Takeda, Teva and UBC.

Siegfried Kasper has received grant/research support from Bristol Myers-Squibb, Eli Lilly, Glaxo-Smith-Kline, Lundbeck, Organon, Sepracor and Servier; has served as a consultant or on advisory boards for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Glaxo-Smith-Kline, Janssen, Lundbeck, Merck Sharp and Dome (MSD), Novartis, Organon, Pfizer, Schwabe, Sepracor, and Servier; and has served on speakers’ bureaus for Angelini, AstraZeneca, Bristol Myers-Squibb, Eli Lilly, Janssen, Lundbeck, Pfizer, Pierre Fabre, Schwabe, Sepracor, and Servier.

Guy Goodwin received grants/research support, consulting fees and honoraria within the last three years from AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Cephalon/Teva, Eisai, Eli Lilly, Lundbeck, Otsuka, P1Vital, Roche, Sanofi-Aventis, Servier, Takeda.

Charles Bowden received grants/research support, consulting fees and honoraria within the last three years from GSK, Sunovion, Teva and the National Institute of Mental Health.

Rasmus W. Licht received consulting fees and honoraria within the last three years from Astra-Zeneca, Bristol-Myers Squibb, Eli Lilly and Lundbeck.

Hans-Jürgen Möller received grant/research support, consulting fees and honoraria within the last three years from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Eisai, Glaxo-Smith-Kline, Janssen Cilag, Lundbeck, Merck, Organon, Pfizer, Sanofi, Schering-Plough, Schwabe, Sepracor, Servier, Wyeth and the German Science Foundation, the German Ministry of Science and the German Ministry of Health.

Notes

1A point of discussion within the task force, raised by JRC, was applying more restrictive criteria for a drug to meet the highest category of evidence (CE) criteria “A”. It was proposed that the optimal bipolar drug development maintenance therapy design should be one in which data are obtained on both recently manic patients and recently depressed patients. This should be considered as the “gold standard” and all of the maintenance studies that limited study entry to just mania or just depression be defined as being at its best Category B – as being less methodologically rigorous and less valid. However, it would have meant creating a CE category content different from the one used in the other WFSBP guidelines. In addition, it was felt that this categorization might give too much weight to discontinuation (enriched) studies and undervalues pure prophylactic studies randomizing euthymic patients, but neither patients in mania nor in depression. Nevertheless, although not applied in this update, the feasibility of this proposal should be tested in parallel in future updates of this guideline.

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