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14th LAP Symposium z Conference Excellence in psychiatry: hopes and hubris Over-confident leaders taking excessive risks, the benefits of early treatment of bipolar disorder, serendipity in the quest for an Alzheimer’s disease treatment along with strategies to minimise harm from drug therapy all played a part in the annual meeting for psychiatrists that is the Latest Advances in Psychiatry Symposium. Steve Titmarsh went along to the Royal College of Physicians in London, in March to find out more. 14 LATEST ADVANCES IN PSYCHIATRY SYMPOSIUM TH EXCELLENCE IN PSYCHIATRY: HOPES AND HUBRIS Thursday 12th March 2015 Royal College of Physicians, Regent’s Park, London A collaboration between Progress and the International Society for Affective Disorders Hubris syndrome The keynote lecture was given by Lord David Owen. He reviewed what he had been writing about hubris syndrome focussing on diminished empathy and unbridled intuition and relationships between the two. Neither is mentioned directly in the 14 signs and symptoms of hubris syndrome (Table 1) which Lord Owen developed with Jonathan Davidson in 2009.1 He considered how his work might develop in future in the hope that he would encourage greater research into hubris syndrome. Lord Owen said hubris is an occupational hazard for political, military and business leaders. Company CEOs may be prone to taking excessive risk and rely more on intuition than rational thought. And even though hubristic behaviour may well have played a part in the downfall of huge international companies with significant impact on national economies, there has been little research into the causes of the behaviour, neurobiological or other, let alone potential treatment. Although risk taking can be destructive, stifling it completely and taking a safe approach to business will affect a capitalist economy; so there is a fine balance to be struck. Indeed, risk exists in life and probably has an important role to play, but it is how risk is handled that is important, Lord Owen said. www.progressnp.com Lord Owen set up the Daedalus Trust (www.daedalustrust.com) to support research into and raise awareness of personality change associated with the exercise of power and the effect on decision making. However, although he acknowledged the importance of medicine and medical treatment, Lord Owen felt he had to resist the medical model as a sole answer to dealing with hubris syndrome as he feels strongly that a more holistic approach is needed, involving all facets of human nature, if an answer to containing and constraining those who develop hubris syndrome is to be discovered. Early intervention in bipolar disorder improves outcomes It is somewhat surprising that, compared with schizophrenia, there are few data on early intervention in bipolar disorder, indeed, Professor Lars Vedel Kessing, Professor of Psychiatry at the Psychiatric Centre Copenhagen and University of Copenhagen, knew of only one study. Early intervention has been shown to result in better outcomes in schizophrenia and Professor Kessing said there are seven indications from obser vational studies that early intervention in bipolar disorder may improve the course and outcome of the illness: 1. The risk of recurrence increases with every new episode2 2. Delay to first treatment is associated with more time depressed, greater severity of depression, greater number of episodes and more days of ultrarapid cycling3 3. Response to lithium monotherapy decreases with the occurrence of multiple prior episodes4 4. The rate of response to lithium in monotherapy is increased when started at first psychiatric contact rather than at later contacts. The same is true for starting lithium at the first ever manic episode4 5. Mood stabilisers prescribed for bipolar disorder may have neuroprotective properties 5,6 so early inter vention may prevent progression 6. The prevalence of cognitive dysfunction may increase with affective episodes and the risk of dementia seems increased by two to three times over ten to 20 years for patients with bipolar disorder compared with the general population7 7. Patients may profit from psychoeducation before potential cognitive disturbances may occur during the long term course of illness.8 Professor Kessing and colleagues have tested whether treatment in a specialised outpatient mood disorder clinic, combining optimised pharmacological treatment with group psychoeducation among Progress in Neurology and Psychiatry May/June 2015 31 Conference z 14th LAP Symposium The Symptoms of Hubris Syndrome Proposed criteria for Hubris Syndrome and their correspondence to features of Cluster B personality disorders in DSM-IV 1. A narcissistic propensity to see their world primarily as an arena in which they can exercise power and seek glory; 2. A predisposition to take actions which seem likely to cast them in a good light – i.e. in order to enhance their image; 3. A disproportionate concern with image and presentation; 4. A messianic manner of talking about what they are doing and a tendency to exaltation; 5. An identification of themselves with the nation, or organisation to the extent that they regard their outlook and interests as identical; 6. A tendency to talk of themselves in the third person or using the royal ‘we’; 7. Excessive confidence in their own judgment and contempt for the advice or criticism of others; 8. Exaggerated self-belief, bordering on a sense of omnipotence, in what they personally can achieve; 9. A belief that rather than being accountable to the mundane court of colleagues or public opinion, the court to which they answer is: History or God; 10. An unshakable belief that in that court they will be vindicated; 11. Loss of contact with reality; often associated with progressive isolation; 12. Restlessness, recklessness and impulsiveness; 13. A tendency to allow their ‘broad vision’, about the moral rectitude of a proposed course, to obviate the need to consider practicality, cost or outcomes; 14. Hubristic incompetence, where things go wrong because too much self-confidence has led the leader not to worry about the nuts and bolts of policy; NPD.6 NPD.1 NPD.3 NPD.2 Unique Unique NDP.9 NPD.1&2 NPD.3 Unique APD3&5 Unique Unique HPD.5 NPD = Narcissistic Personality Disorder only in DSM-IV; APD = Anti Social Personality Disorder in both DSM-IV & ICD-10; HPD = Histrionic Personality Disorder in both DSM-IV & ICD-10 Table 1. The symptoms of Hubris Syndrome (Reproduced from Owen D, Davidson J. Hubris syndrome: An acquired personality disorder? A study of US Presidents and UK Prime Ministers over the last 100 years. Brain 2009;132:1396–406) patients discharged after their first, second or third hospitalisation for bipolar disorder, is better than standard psychiatric outpatient treatment in the early course of bipolar disorder.9 Patients were followed for up to six years. Time to readmission was significantly longer among patients who received specialised care (n=72) compared with patients who received standard care (n=86) (HR 0.60, 95% CI 0.37 – 0.98; p=0.043). Professor Kessing said that 32 represented a substantial effect of specialised care. In the early days after discharge when the risk of suicide, for example, is 240 times greater than among the general population, the number of patients who had specialised care relapsing was less than among those treated with standard care. After two years patients who received specialised care reverted to standard care. However, Professor Kessing pointed out the relapse rate remained lower than Progress in Neurology and Psychiatry May/June 2015 among patients who received standard care from the beginning of the study. That is in contrast to what is seen in early intervention in schizophrenia.10 Further analysis of Professor Kessing’s study revealed that total time spent in hospital was significantly less for patients who received specialist care compared with those who received standard care (median 33 days vs 49 days; p=0.01). Patients who had received specialist care showed greater adherence to mood stabiliser (59% vs 32.4%; p=0.001) and antipsychotic medication (59.5% vs 34.9%; p=0.01) as reported by patients at two years. In economic terms the specialist ser vice makes sense too. Analysis of two-year treatment costs show that the total direct net cost (including saved hospital beds) was 3,194 Euros less per patient in the specialist ser vice compared with standard care, or 11% of the cost of standard care. Lastly, Professor Kessing said there is a general belief that young patients (under 25 years of age) with bipolar disorder are difficult to treat. However, Professor Kessing’s study shows that outcomes were best for patients aged 18-25 years treated in the mood disorder clinic (n=29; HR 0.33, 95% CI 0.10-1.07; p=0.064).11 Will we ever have effective dementia treatments? One in three people will die with dementia and virtually everyone will be touched by it some way, Professor Robert Howard, Professor of Old Age Psychiatr y and Psychopathology at King’s College, London, told the meeting. In mild, moderate and severe Alzheimer’s disease cholinesterase inhibitors offer modest improvements in cognitive function and activities of daily living (ADL). But www.progressnp.com 14th LAP Symposium www.progressnp.com HAL 1st RIS 3rd ARI LIT QTP OLZ 3rd 1st 5th ranking for efficacy the drugs have no effect on overall decline.12 And when the drugs are stopped there is quite a profound withdrawal effect involving worsening cognition and function and earlier nursing home placement.13 The evidence for treatment of behavioural symptoms and psychosis in AD is not as good as that for cognition and ADL. Only risperidone has an evidence base to show that it is convincingly superior to placebo in treatment of agitation, aggression and psychosis in AD. Indeed, risperidone is the only drug that has a licence for treatment of aggression in AD in Europe. And once an antipsychotic is stopped psychosis returns.14 Disappointingly the cholinesterase inhibitors and memantine are ineffective in treating behavioural symptoms and psychosis in AD.15 Sadly, despite knowing the pathology and neuroscience of dementia and a US$60billion investment in research by the pharmaceutical industry there is as yet no sign of disease modifying treatments for AD. Of the 101 drugs that have come to trial in the last ten years none have progressed beyond phase III. But there may still be hope: ‘Almost all psychiatric treatments were not discovered through translational development but through serendipity,’ Professor Howard said. Repurposing – taking a drug that has one indication and testing it for a new indication that it shows some promise for – could prove fruitful. One example is a trial with nilvadipine, a calcium-channel blocker developed for treating hypertension16 which seems to promote excretion of amyloid in the urine. Another involves minocycline17 for which there is evidence of neuroprotection. A second glimmer of light is hippocampal neurogenesis. There z Conference 7th CBZ ASE ZIP 9th VAL LAM 11th PBO TOP 13th GBT 13th 11th 9th 7th 4th ranking for acceptability Figure 1. Comparative efficacy and acceptability of antimanic drugs in acute mania (Reproduced from: Cipriani, A et al: Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis Lancet 2011; 378:1306-15 (copyright Elsevier)) is evidence to show that people produce 700 new neurones a day in each hippocampus right into their seventies. 18 If that process could be stimulated there may be a benefit in people with AD. What do the latest guidelines say about bipolar disorder? In terms of treatment, there has been a big shift in the most recent version of NICE clinical guideline on bipolar disorder compared with previous versions.19 While previous guideline focussed around medications to reduce symptoms, stabilise mood and prevent relapse, the new guidance gives much greater prominence to psychological interventions, Dr Matthew Taylor, Senior Lecturer at King’s College, London, told delegates. The latest NICE guideline includes a separate section on primary care recognition and management. The guideline does not recommend using questionnaires in primary care to identify bipolar disorder in adults (in contrast to recommendations in the previous edition of the guideline on secondar y care assessment advice). Psychological inter ventions for bipolar depression can be initiated. But primary care initiation of lithium or valproate is not recommended. Triggers for referral or re-referral to secondary care are similar to the previous guideline: – poor or partial response to treatment – functioning declines significantly – treatment adherence is poor Progress in Neurology and Psychiatry May/June 2015 33 Conference z 14th LAP Symposium – comorbid alcohol or drug misuse is suspected – the person is considering stopping any medication after a period of relatively stable mood. And two new triggers for referral or re-referral: – the person develops intolerable or medically important side effects from medication – a woman with bipolar disorder is pregnant or planning a pregnancy. In secondary care, questionnaires are no longer recommended for assessment, which Dr Taylor felt was interesting as he has always found them quite useful as a starting point. For mania or hypomania in people not taking an antipsychotic or mood stabiliser NICE recommends first-line haloperidol, olanzapine, quetiapine or risperidone. If the person is already taking lithium then clinicians should consider adding haloperidol, olanzapine, quetiapine or risperidone, after checking the patient’s plasma lithium levels to optimise treatment. A new recommendation is that lamotrigine should not be used to treat mania (Figure 1). For people taking antidepressant monotherapy who develop mania or hypomania, stopping the antidepressant should considered and an antipsychotic offered whether or not they stop the antidepressant. The CANMAT guidelines 20 style is ver y different with quite complicated algorithms, but Professor Howard felt they complement the NICE guidelines. BAP guidelines21 are similar to NICE, starting with antipsychotics or valproate and recommending lithium for milder manic symptoms. Bipolar depression is more challenging. Recently, with new treatments and well run trials there is more hope in this area. 34 NICE recommends starting with psychological interventions such as those specifically developed for bipolar disorder that have a published evidence based manual on how they should be delivered, or a high intensity psychological intervention (cognitive behavioural therapy, interpersonal therapy or behavioural couples therapy) in line with the NICE clinical guideline on depression. Dr Taylor commented that the recommendation to use psychological therapies is perhaps driven less by evidence, which is mostly of low or very low quality, and more by service user demand. One disadvantage of this approach is that it might impede the development of more effective treatments, he added. SSRIs are no longer recommended by NICE for bipolar depression. An olanzapine / fluoxetine combination or quetiapine are recommended first-line with lamotrigine or olanzapine secondline. Some trials seemed have been missed in the evidence gathered by NICE. That has been addressed in an online analysis by Taylor and colleagues from the Maudsley.22 Relapse prevention is a big part of bipolar treatment. A new recommendation in the NICE guideline for people who have some persisting symptoms between episodes of mania or bipolar depression is to offer a structured psychological intervention (individual, group or family). Dr Taylor commented that group therapy seems to be more effective than one-to-one sessions.23 That’s good news in these cash-strapped times because group therapy is a little less expensive to deliver than the individual format, he commented. When planning long-term drug treatment to prevent relapse the NICE guideline says clinicians should discuss with people Progress in Neurology and Psychiatry May/June 2015 whether they want to stay with their current treatment or switch to lithium. It should be explained that lithium is the most effective long-term treatment for bipolar disorder. Dr Taylor commented: ‘I am a great fan of lithium. I think it’s probably underused but I am not entirely sure whether you can say it’s the most effective long-term treatment for bipolar disorder.’24 Indeed, in Dr Taylor’s opinion, the options for long-term treatment recommended by NICE are fairly limited: lithium first line with the addition of valproate if it is ineffective. Valproate or olanzapine are recommended for those patients who do not tolerate lithium or do not agree to routine blood monitoring, or a new recommendation, to offer quetiapine for those who responded during an episode of mania or bipolar depression. Dr Taylor concluded by saying it is clear now that treatments for bipolar disorder are not like-forlike equivalents. They differ in clinically important ways and in terms of efficacy. And the drugs that work for the acute phase seem to work in a proportionate way in the long term.25 Risk management of medicines Professor Saad Shakir, Director of the Drug Safety Research Unit in Southampton, discussed some of the strategies employed to monitor medicines and to try to reduce some of associated risks when they move from the somewhat artificial realms of clinical trials into the real world where they may be taken by patient groups who may not have been represented in trials. Pharmacovigilance and risk management are important because: • 5% of all hospital admissions are for ADRs26 • 5% of all hospital inpatients suffer an ADR www.progressnp.com 14th LAP Symposium • ADRs are the 5th most common cause of hospital death • Estimated 197,000 deaths in the EU from ADRs • EU societal cost of ADRs is 79 billion Euros per year Clinical trials are limited in their ability to pick up adverse reactions to drugs, not least because they often include too few patients, inclusion criteria are too restrictive, they run for too short a time and do not reflect real world practice. Thus when a drug is used in the wider world it is important risk management is instituted which involves a set of pharmacovigilance activities and inter ventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions. Secondary care event monitoring studies are one means by which pharmacovigilance data can be captured. Many of these are required as part of the licensing of some drugs. References 1. Owen D, Davidson J. Hubris syndrome: An acquired personality disorder? A study of US Presidents and UK Prime Ministers over the last 100 years. Brain 2009;132:1396–406. 2. Kessing LV, Hansen MG, Andersen PK, et al. Course of illness in depressive and bipolar disorders. Naturalistic study, 1994-1999. Br J Psychiatry 2004;185:372-7. 3. Post RM1, Leverich GS, Kupka RW, et al . Early-onset bipolar disorder and treatment delay are risk factors for poor outcome in adulthood. J Clin Psychiatry 2010;71(7):864-72. 4. Kessing LV, Hellmund G, Geddes JR, et al. Valproate v. lithium in the treatment of bipolar disorder in clinical practice: observational nationwide register-based cohort study. Br J Psychiatry 2011;199(1):57-63. 5. Manji HK, Moore GJ, Rajkowska G, et al. Neuroplasticity and cellular resilience in mood disorders. Mol Psychiatry 2000;5:578-93. 6. Fountoulakis KN. The contemporary face of bipolar illness: complex diagnostic and therapeutic challenges. CNS Spectr 2008;13(9):76374,777-9. 7. da Silva J, Gonçalves-Pereira M, Xavier M, et al. Affective disorders and risk of developing dementia: systematic review. Br J Psychiatry 2013;202:177-86.) 8. Berk M, Dodd S, Callaly P, et al. History of illness prior to a diagnosis of bipolar disorder or schizoaffective disorder. J Affect Disord 2007;103:181–6. 9. Kessing LV, Hansen HV, Hvenegaard A, et al. Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder: randomised clinical trial. Br J Psychiatry 2013;202:212-9. 10. Bertelsen M, Jeppesen P, Petersen L, et al. Five-year follow-up of a randomized multicenter trial of intensive early intervention vs standard treatment for patients with a first episode of psychotic illness. The OPUS trial. Arch Gen Psychiatry 2008;65(7):762-71. 11. Kessing LV, Hansen HV, Christensen EM, et al. Do young adults with bipolar disorder benefit from early intervention? J Affect Disord 2014;152-154:403-8. 12. Courtney C, Farrell D, Gray R, et al. Longterm donepezil treatment in 565 patients with Alzheimer’s disease (AD2000): randomised double-blind trial. Lancet 2004;363 (9427):2105-15. 13. Howard R, McShane R, Lindesay J, et al. Donepezil and memantine for moderate-tosevere Alzheimer’s disease. N Engl J Med 2012; 366:893-903. 14. Katz IR, Jeste DV, Mintzer JE, et al . Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: A randomized, doubleblind trial. Risperidone Study Group. J Clin Psychiatry 1999;60:107-15. 15. Howard RJ, Juszczak E, Ballard CG, et al. z Conference Donepezil for the treatment of agitation in Alzheimer’s disease. N Eng J Med 2007; 357(14):1382-92. 16.https://clinicaltrials.gov /ct2/show/NCT02017340 (last accessed April 2015). 17.http://public.ukcrn.org.uk /search/StudyDetail.aspx?StudyID=14866 (last accessed April 2015). 1 8 . w w w. a l z f o r u m . o r g / n e w s / r e s e a r c h news/newborn-neurons-abundant-adulthuman-hippocampus (last accessed April 2015). 19. Bipolar Disorder. The NICE guideline on the assessment and management of bipolar disorder in adults, children and young people in primary and secondary care. CG185. Nice.org.uk/guidance/cg185 (last accessed April 2015). 20. Yatham LN, Kennedy SH, Parikh SV, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013. Bipolar Disord 2013;15:1-44. 21. Goodwin GM. Evidence-based guidelines for treating bipolar disorder: revised second edition – recommendations from the British Association for Psychopharmacology. J Psychopharmacol 2009;23(4):346-88. 22. Taylor DM, Cornelius V, Smith L, et al . Comparative efficacy and acceptability of drug treatments for bipolar depression: a multipletreatments meta-analysis. Acta Psych Scand 2014;130:452-69. 23. Bond K, Anderson IM. Psychoeducation for relapse prevention in bipolar disorder: a systematic review of efficacy in randomized controlled trials. Bipolar Disord 2015 Jan 16. doi: 10.1111/bdi.12287. 24. Miura T, Norria H, Furukawa TA, et al . Comparative efficacy and tolerability of pharmacological treatments in the maintenance treatment of bipolar disorder: a systematic review and network meta-analysis. Lancet Psychiatry published online 15 September 2014. DOI: http://dx.doi.org/10.1016/S22150366(14)70314-1 (last accessed April 2015). 25. Taylor MJ. Bipolar treatment efficacy. Lancet Psychiatry 2014;1:418. 26. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004;329:15. Visit us online Progress in Neurology and Psychiatry’s dedicated website www.progressnp.com features news, events diary, CMHP reviews, journal supplements as well as current and archived issues of Progress. www.progressnp.com www.progressnp.com Progress in Neurology and Psychiatry May/June 2015 35