BAP Guidelines Evidence-based guidelines for treating Journal of Psychopharmacology 23(4) (2009) 346–388 bipolar disorder: revised second © The Author(s), 2009. Reprints and permissions: — http://www.sagepub.co.uk/ edition recommendations journalsPermissions.nav ISSN 0269-8811 from the British Association for 10.1177/0269881109102919 Psychopharmacology GM Goodwin University Department of Psychiatry, Warneford Hospital, Oxford, UK. Consensus Group of the British Association for Psychopharmacology Abstract The British Association for Psychopharmacology guidelines specify the extensive feedback from participants and interested parties. The strength scope and target of treatment for bipolar disorder. The second version, like of supporting evidence was rated. The guidelines cover the diagnosis of the first, is based explicitly on the available evidence and presented, like bipolar disorder, clinical management, and strategies for the use of previous Clinical Practice guidelines, as recommendations to aid clinical medicines in treatment of episodes, relapse prevention and stopping decision making for practitioners: they may also serve as a source of treatment. information for patients and carers. The recommendations are presented together with a more detailed but selective qualitative review of the available evidence. A consensus meeting, involving experts in bipolar Key words disorder and its treatment, reviewed key areas and considered the strength antidepressants; antipsychotics; bipolar disorder; CBT; depression; of evidence and clinical implications. The guidelines were drawn up after evidence-based guidelines; lithium; mood stabilizers; treatment Introduction rent consensus. Where there is no consensus, discussion can only highlight the differences not resolve them. Guidelines are systematically derived statements that are The first BAP guidelines for bipolar disorder were published in aimed at helping individual patient and clinician decisions. 2003 (Goodwin, 2003). This is a substantial revision of that The principal recommendations given here usually apply to original document. However, where consensus remains as it the average patient. They need to be graded according to the was, the references in this review have not been systematically strength of the evidence from appropriate, preferably rando- revised. We have attempted to establish points of genuine cur- mised trials. Such recommendations may be expected to apply BAP Administrator: Susan Chandler, BAP Office, Cambridge ([email protected]). The Consensus Group was as follows: Ian Anderson ([email protected]); Francesc Colom ([email protected]); David Coghill ([email protected]); John Cookson ([email protected]); Nicol Ferrier ([email protected]); John Geddes ([email protected]); Guy Goodwin ([email protected]); Peter Haddad ([email protected]); Neil Hunt ([email protected]); Nav Kapur ([email protected]); Ian Jones ([email protected]); Dominic Lam ([email protected]); Anne Lingford-Hughes ([email protected]); David Miklowitz ([email protected]); Richard Morriss ([email protected]); Barbara Sahakian ([email protected]); Jan Scott ([email protected]); David Taylor ([email protected]); Jogin Thakore ([email protected]); Anita Thapar ([email protected]); Alan Thomas ([email protected]); Philip McGuire ([email protected]); Stephen Cooper ([email protected]); Philip Cowen ([email protected]); Chris Manning (Primhe) ([email protected]); Klaus Ebmeier ([email protected]); Jonathan Cavanagh ([email protected]). Observers and reviewers from Royal College of Psychiatry Special Interest Group: Thomas Barnes ([email protected]); Katheine J Aitchison ([email protected]). Participants from AstraZeneca, Bristol Myers Squibb, GSK, Eli Lilly, Sanofi-Aventis. Corresponding author: GM Goodwin, University Department of Psychiatry, Warneford Hospital, Oxford OX3 7JX, UK Evidence-based guidelines for treating bipolar disorder 347 about 70% of the time so we have used expressions like ‘Clin- Services Research, University of Newcastle upon Tyne and the icians should consider...’ in the text. However, there will be Centre for Health Economics, University of York (Shekelle, occasions when adhering to such a recommendation unthink- et al., 1999b). ingly could do more harm than good. We have also recommended options. These systematically Evidence categories derived statements are not prescriptive. We have phrased Evidence categories are developed from Shekelle, et al. (1999a). options as ‘Clinicians may…’ or ‘Clinicians may consider...’. They recognise that implementation will depend on individual Categories of evidence for causal relationships and treatment and local circumstances. Options provide a summary of up- to-date evidence and may highlight current uncertainties. I evidence from meta-analysis of RCTs,a at least one large, Finally some of our recommendations may be regarded as good quality, RCTa or replicated, smaller RCTsa standards of care. Standards are intended to apply in practi- II evidence from small, non-replicated RCTs,a at least one cally all circumstances. Many standards are driven by ethical controlled study without randomisation or evidence from consensus rather than evidence. Where standards are evidence- at least one other type of quasi-experimental study based, confidence and consensus must be very high, perhaps III evidence from non-experimental descriptive studies, such as requiring that standards be adhered to >90% of the time. We uncontrolled, comparative, correlation and case-control have phrased such recommendations in the imperative or as a studies directive. IV evidence from expert committee reports or opinions and/or This approach to making recommendations of policy is well clinical experience of respected authorities established (Eddy, 1990). In general, we have tried to ensure that our recommendations reflect both the degree of certainty Proposed categories of evidence for non-causal relationships about what will happen if any given policy is followed and the extent to which the patient’s and clinician’s preferences are I evidence from large representative population samples consistent with the likely outcomes. II evidence from small, well designed but not necessarily rep- resentative samples III evidence from non-representative surveys, case reports Methodology IV evidence from expert committee reports or opinions and/or clinical experience of respected authorities This document is the result of an initial meeting held on 18th May 2007. Brief presentations were made on key areas in Strength of recommendation Recommendations are graded A which new data has become available, with an emphasis on to D as shown below. While it is possible to have methodologi- systematic reviews and randomised controlled trials (RCTs). cally sound (category I) evidence about an area of practice that These were followed by a discussion of the important issues is clinically irrelevant or has such a small effect that it is of little in order to identify consensus, on the one hand, and areas of practical importance, in practice, the volume of the available uncertainty on the other. A literature review was then assem- evidence has been limited and this has scarcely been an issue. bled formally to justify the consensus points. This review More commonly, it has been necessary to extrapolate from the together with recommendations and their strength, based on available evidence or opinion. This leads to weaker levels of rec- the level of evidence, were circulated to participants and other ommendation (B, C or D), but such recommendations may still interested parties. Their feedback was, as far as possible, incor- cover key areas of practice. Where recommendations are not porated into the final version of the guidelines. strictly based on systematic evidence at all, but represent an important consensus (practical or ethical) we have indicated S Identification of relevant evidence (standard of care), but we do not review these points in depth. All the consensus points and the guideline recommendations A directly based on category I evidence can be linked to relevant evidence through the literature B directly based on category II evidence or extrapolatedb rec- review. However, our methodology did not allow for a system- ommendation from category I evidence atic review of all possible data from primary sources. Existing systematic reviews and RCTs were identified primarily from MEDLINE and EMBASE searches. a RCTs must have an appropriate control treatment arm; for primary efficacy this should include a placebo condition Strength of evidence and recommendations for guidelines Ca- although for psychological treatments this may not be met. tegories of evidence for causal relationships (including treat- b Extrapolation may be necessary because of evidence that is ment) and grading of recommendations are taken from the only indirectly related, covers only a part of the area of practice methodology of the North of England Evidence-Based Guide- under consideration, has methodological problems or is line Development Project undertaken by the Centre for Health contradictory. 348 Evidence-based guidelines for treating bipolar disorder C directly based on category III evidence or extrapolatedb These differences usually result from different weights placed recommendation from category