experimental bipolar treatments

Risk assessment has poor positive predictive value for adverse outcomes and should not be over-emphasized in management (I). Such studies enrich the study sample for acute responders to the drug of interest, and the active drug may be withdrawn abruptly, which risks amplifying any drug/placebo difference with withdrawal effects. It is required to be inconsistent with development and to occur frequently (on average, three or more times per week). Any medication used adjunctively for symptomatic effect to promote sleep or sedation should be discontinued as soon as symptoms improve (S). Accordingly, claims that drugs used in pregnancy cause adverse behavioural outcomes should be treated cautiously. The highest dose that produces minimal adverse reactions and effects should be employed. A drug-induced state, including psychosis, should wane with the clearance of the offending drug (II): use 5 half-lives as the relevant interval (and the longest half-life stated in a range). Thus, comparisons in RCTs include many indirect (placebo) and direct comparisons; this reduces the risk that unblinding and other bias has significantly distorted the results in individual studies. Abuse and neglect are also associated with impairments of memory and executive function in bipolar patients (Savitz et al., 2008) and may increase the risk of psychosis (Read et al., 2005). (, Bolea-Alamanac, B, Nutt, DJ, Adamou, M. (, Bourne, C, Aydemir, O, Balanza-Martinez, V. (, Bowden, CL, Calabrese, JR, McElroy, SL. Recommendations will be starred as in Table 2. There is a reluctance to make a diagnosis in young people with bipolar disorder, which is to some extent reinforced by NICE2014. Network meta-analysis ranks them below the more efficacious dopamine antagonists (Cipriani et al., 2011), but their use may often be considered if planning their long-term continuation. When prescribing lithium, the practice standards (derived from NICE guidance) require that a patient be informed at the start of treatment about the potential adverse reactions, how they could recognize toxicity and how they should avoid toxicity. The use of a scale such as the Inventory of Depressive Symptomatology (IDS) or Quick Inventory of Depressive Symptomatology (QIDS), which maps to the diagnostic features, gives a severity estimate. A systematic review of over 4000 women with bipolar disorder or post-partum psychosis confirmed that post-partum relapse rates were significantly higher among those who were medication free during pregnancy (66%, 95% CI 57–75) than those who used prophylactic medication (23%, 95% CI 14–37) (Wesseloo et al., 2016). In GRADE terminology, a coherent network supports strong ranking for treatment recommendations based on RCTs; a sparse or unstable network does not. The affinities at other receptors are both multiple and varied (Michl et al., 2014). The illness had also affected the carers’ emotional health and life in general. diagnosis of bipolar I disorder) (***). If it works, a personalized approach to IPSRT-derived self-management could be made widely available and integrated into clinical care. These studies are required by the EMA as proof of continuing efficacy for drugs shown to be effective in short-term studies of acute illness. At present the preferred strategy is for continuous rather than intermittent treatment with oral medicines to prevent new mood episodes. In the US it has a licence for the acute treatment of bipolar depression as well as schizophrenia. Cariprazine is a highly selective dopamine D3 and D2 receptor partial agonist with preferential binding to D3 receptors. The full agonist pramipexole has also been reported to show efficacy in small studies in treatment-resistant unipolar and bipolar depression (Dell’Osso and Ketter, 2013; Zarate et al., 2004). Maternal depression has a negative effect on child development (Rice et al., 2007). There are no specific treatments for rapid cycling. NICE2014 made a distinction between primary and secondary care implying that there are mild cases of bipolar disorder that can be managed with psychological treatment alone. There remains some interest in using topiramate for weight reduction in obese bipolar patients (Chengappa et al., 2006). In common with a number of other drugs for psychosis, quetiapine has moderate affinity for dopamine D2 and serotonin 5-HT2A receptors. Previous US Guidelines gave unusual weight to the efficacy data for valproate and the conviction that lithium and valproate are ‘mood stabilizers’ (see below). Thus, the asymmetry may be a consistent finding and reflect the greater acute efficacy of dopaminergic drugs. Of course, clinically there is an obvious gradient between patients with highly variable mood and those with a much more episodic pattern. The following general principles are important. The partial way in which the data appears to have been reviewed by NICE2014 to justify their conclusions has also been highlighted (Jauhar et al., 2016). It is not established that early rashes “progress” to Stevens–Johnson syndrome and toxic epidermal necrolysis, even when the early rash is erythema multiforme. The sleep of bipolar patients between episodes is often disturbed in a very similar way to that of patients with primary insomnia (Harvey et al., 2005). The separation from the latter is a potential source of confusion in the coming years. (, Stratford, HJ, Cooper, MJ, Di Simplicio, M. (, Suppes, T, Baldessarini, RJ, Faedda, GL. In general, effect sizes for drug treatment of anxiety disorders appear to be greater than for psychological treatments (Bandelow et al., 2015). Current practice also favours didactic teaching, live or by video, written materials or guided internet searching for high-quality material (e.g. These issues are most relevant to lithium, given its low therapeutic index. (, van der Loos, MLM, Mulder, PGH, Hartong, EGTM. These negative aspects of long-term outcome are often accepted as the natural history of the disease. Aripiprazole and quetiapine are approved to treat mania symptoms in children 10–17 years old who have bipolar I, while olanzapine is approved for use in children ages 13–17. We are impressed by the power of network meta-analysis for understanding treatment efficacy, and we will refer to such analyses in supporting the use of medicines to treat different aspects of bipolar disorder. Enhancement of patient care can be achieved by structured interventions based on psychoeducation (II). Any patient who is being treated for depression should be asked if they have a personal history of abnormal mood elevation of any duration or a family history of affective disorder (IV, opinion of consensus group). Nevertheless, the principal recommendations usually derive from average effects in patient populations. A preliminary investigation of the families of 86 stable patients showed that caregivers still showed a moderate level of subjective burden. Nevertheless, it is potentially toxic and there is an important potential for litigation if accepted procedures are not followed. Caffeine (in coffee and other drinks) may significantly disturb sleep and exacerbate anxiety symptoms in sensitive individuals (III). Thus, 52% of women who discontinued lithium during pregnancy relapsed and 70% of the women who remained stable after lithium discontinuation during pregnancy relapsed in the post-partum period (Meyer and Koro, 2004; Viguera et al., 2000). A further finding was that approximately one in five patients who started lithium had no documented baseline test of renal function or thyroid function, and this proportion remained relatively consistent over 5 years (2008–2013). These rates are high, which seems likely to have been due to the inclusion of rapid cycling patients. Discuss the use of alcohol, tobacco, prescription and non-prescription medication and illicit drugs with the person, and their carer if appropriate. We will recommend DSM-5 criteria in this text. Identify and treat conditions such as hypothyroidism or substance use that may contribute to cycling (**). Finally, in the UK only aripiprazole is licensed for up to 12 weeks’ treatment of moderate to severe manic episodes in bipolar I disorder in young people (13 years and older). Treatment with effective nicotine substitutes will often be indicated (IV). We recommend the corresponding BAP guidelines for attention deficit hyperactivity disorder (Bolea-Alamanac et al., 2014), anxiety disorders (Baldwin et al., 2014) or substance misuse (Lingford-Hughes et al., 2012). Rapid cycling obviously implies temporal severity and it may often be difficult to treat. trustworthy health. Twice a day dosing may be associated with a higher risk of renal side effects. The earliest symptoms that a patient experiences may be those of anxiety but the dominant picture subsequently may be mania and depression. Borderline personality disorder is an important diagnosis that may either be confused with or be co-morbid with bipolar disorder. There also needs to be a shared and consistent approach across mental health disciplines. The early diagnosis of bipolar disorder may not be easy. All maternal drugs enter breast milk, but the ratio between infant and maternal plasma concentrations varies greatly. However, the extensive experience of using antidepressants in unipolar disorder means that this is not an important limitation, except potentially with the risk for switch to mania. The National Service Framework for Mental Health recognized the vital role of informal carers in the delivery of mental health care (Department of Health, 1999). Consider the needs of carers and children of patients with bipolar disorder: provide information about local or national support groups (S). There is a risk of a switch to mania or mood instability during treatment for depression (I). The key to success with individual patients is cautious but confident prescribing of adequate doses and monitoring of effects, both positive and negative. Existing pharmacological treatments for bipolar disorder (BPD), a severe recurrent mood disorder, is in general insufficient for many patients. Retention of patients in a 1–2-year study may be as low as 10%. Relative effects on the manic and depressive poles of the illness appear to depend on the complex pharmacology of the drugs but may be predicted by acute treatment effects. Prolactin and gonadal function are hardly ever assessed in women on dopamine antagonists, BMD is not measured, and osteoporosis remains undiagnosed, let alone prevented or treated. It has been demonstrated to show efficacy in two short-term studies in bipolar depression: one as monotherapy and the other as add-on to lithium or valproate (Loebel et al., 2014a, 2014b). This is probably higher than appreciated (Van Meter et al., 2011). The Founder of the Centre, Dr Zamar noted, “The biggest challenge facing bipolar disorder sufferers is the significant side effects burden which comes with traditional treatments. Discontinuation of an antidepressant should follow recommendations in related BAP guidelines and taper over 4 weeks if possible (Cleare et al., 2015). Whether psychological interventions can be modified to be efficacious in patients with many previous episodes. A longer list of possible contributory factors emerges from a broad review of the literature (Pompili et al., 2013); the contribution of individual risks is poorly quantified and many are likely to be confounded. The Maudsley Bipolar Disorder Project: Executive dysfunction in bipolar disorder I and its clinical correlates, Two-year outcomes for interpersonal and social rhythm therapy in individuals with bipolar I disorder, Interpersonal and social rhythm therapy: Managing the chaos of bipolar disorder, Divalproex sodium treatment of women with borderline personality disorder and bipolar II disorder: A double-blind placebo-controlled pilot study, Bouncing back: Is the bipolar rebound phenomenon peculiar to lithium? Broadly speaking, the interventions that have been offered in bipolar disorder are pragmatically directed to identified clinical problems. Block, MD. There may be a risk in bipolar II disorder, that antidepressants induce hypomania, mixed states or rapid cycling. The use of muscarinic antagonists (antiparkinsonian medication) provides a proxy for clinically significant extrapyramidal symptoms. Measures of blinding should be included in all such studies for patients and raters, but are often omitted or not reported. Most newly introduced treatments for bipolar disorder, whether pharmacological or psycho logical, have been based on an extension of use from another disorder—eg, antipsychotics in mania and antidepressants or cognitive-behavioural therapy for bipolar depression. If the rash is trivial and disappears, lamotrigine can be reintroduced even more slowly. A consistent long-term flexible alliance between the patient, the patient’s family and key members of a psychiatric team, including an effective, appropriately trained psychiatrist, is the ideal arrangement for outpatient care. In conclusion, very little work has pragmatically addressed the best model of service delivery for bipolar patients. Treatment guidelines (Sachs et al., 2000) have repeatedly suggested an overwhelming expert preference for the use of lithium as first-line treatment rather than antidepressants. The first study on acupuncture as an add-on therapy for bipolar disorder is currently underway in the US. The role of structured psychological treatment in the management of bipolar disorder remains at an experimental and exploratory level. Long-term treatment is indefinite and for the prevention of new episodes. It appears to be almost exclusively effective against manic relapse (I). There is evidence that gambling is in part a way to regulate mood, but mood elevation also enhances enjoyment (Lloyd et al., 2010). The Neuroscience-based Nomenclature (NbN) is a new system to promote the description and classification of psychotropic drugs in this way. This is 20-fold greater than population rates and translates into risks at long-term follow-up between 3–6% (I, (Chesney et al., 2014; Crump et al., 2013)), which are amongst the highest for any psychiatric disorder. In addition, the availability of network meta-analysis of RCTs has given us the opportunity to re-think how to contextualize the quality of the evidence for an individual drug in the overall treatment strategy. This acute episode is the focus of initial treatment. The doses employed in trials were high (300–600 mg/day) and in the monotherapy trial the median dose was 546 mg/day (Weisler et al., 2011). The patient and clinician may decide to continue the drug that proved effective in the treatment of acute mania; this will often be a dopamine antagonist/partial agonist. Suicide has never been the primary outcome measure for a clinical trial in bipolar disorder, because in practice observable rates are too low. They have been investigated in poor-quality clinical trials (III or less). Publication in a high-profile journal or endorsement in a guideline will increase the demand for workshops and training that may remunerate a provider personally, and will be used to demonstrate impact by their employing institution. Consider disulfiram if patient wants abstinence and if acamprosate and naltrexone have failed. Indeed, for dopamine antagonists and serotonin re-uptake inhibitors there were no differences in effect size between industry-supported and non-industry-supported trials when the designs were similar (Lundh et al., 2012). As we argue in the preceding paragraph, practice can be underpinned by the knowledge that the efficacy of the treatment choices has been established in RCTs with a coherent network. When prescribed regularly at night they may also facilitate the return of a normal sleep–wake cycle (II, (Post et al., 1996)). Specific anxiety-focused psychological treatments – such as trauma-focused CBT and CBT for social anxiety – are recommended rather than ‘generic CBT’. This is an area likely to see major advances in the coming years and, hopefully, clarification of what really helps. Thus, one cannot usually start a patient on a therapeutic dose of lithium on the first day of treatment, whereas this can often be achieved with a dopamine antagonist or partial agonist. The goal of acute bipolar disorder treatment is to rapidly stabilize th… For perhaps too long, monotherapy with lithium was believed to be the best treatment for bipolar disorder. However, the monotherapy studies in bipolar depression may have failed because of shortcomings in the trial design, and the relapse prevention study was clearly under-powered to detect effects on depressive relapse. Repeated transcranial magnetic stimulation (rTMS) is also being studied for depression and bipolar disorder. The NICE and BAP guidelines for these primary anxiety disorders detail the specific pharmacological approaches. Psychosis or mania is a particular risk for bipolar I disorder: it is increased further by a previous post-partum episode. Cognitive and functional remediation, as prescribed in group format (Vieta et al., 2014), may be helpful to improve global as well as interpersonal and occupational functioning (Torrent et al., 2013). It appears currently to be under-used outside expert centres. Department of Psychiatry, ... and using experimental or putative treatments for persistent rapid cycling after more traditional treatments have failed. The drugs tested enhanced noradrenaline and/or serotonin function by inhibiting monoamine re-uptake or metabolism. (, Greil, W, Ludwig-Mayerhofer, W, Erazo, N. (, Hartong, EGTM, Moleman, P, Hoogduin, CAL. Read the latest medical research on causes, symptoms and new treatments for bipolar disorder. This estimate depends on where the boundary between bipolar II and subthreshold bipolarity is drawn. (, Rummel-Kluge, C, Komossa, K, Schwarz, S. (, Sachs, GS, Nierenberg, AA, Calabrese, JR. (, Samren, EB, van Duijn, CM, Christiaens, GC. The efficacy of lamotrigine has been uncertain for acute bipolar depression. Polypharmacy may also compound the problem (Clark et al., 2002; Frangou et al., 2005). In young patients, generally, behavioural disturbance may be interpreted as the maturational tensions of adolescence. This can lead to worsening problems with mood and functioning. Weight and other relevant risk factors should be monitored at least annually and treatment offered appropriately (S). Always talk to your doctor before starting an alternative treatment. Therefore their efficacy showed that an anti-manic action could be achieved in the absence of extrapyramidal symptoms (II, (Keck et al., 2000)). For example, the glomerular filtration rate increases during pregnancy, causing many medications to be excreted more rapidly. NICE suggested a structured psychological intervention (individual CBT or interpersonal therapy) of at least 3 months’ duration for bipolar depression. drugs shown to be effective in major depressive episodes with a unipolar course) (IV). Chronic symptoms in bipolar disorder are commonly depressive (II, (Judd et al., 2002, 2003; Kupka et al., 2007)) and significant levels of residual symptoms are predictive of relapse (Judd et al., 2008). Although it is conventional in discussing unipolar disorder to distinguish relapse (the early return of symptoms treated in an acute episode) from recurrence (the return of symptoms after remission), this is a distinction that is rarely helpful in bipolar disorder with relatively frequent episodes. The e-mail addresses that you supply to use this service will not be used for any other purpose without your consent. Antidepressants are usually present in breast milk in low concentration but there is large individual variation and some infants have developed plasma concentrations higher than maternal plasma concentrations. Clinicians should make accurate diagnoses of hypomania, mania and depression (Standard of Care, (S)). The anergic pattern of illness often seen in bipolar patients may favour the use of activating antidepressants such as monoamine oxidase inhibitors (MAOIs) (IV). There was no excess of depressive episodes in lithium-treated patients nor manic episodes in lamotrigine-treated patients compared with placebo. The NICE guideline on borderline personality disorder (https://www.nice.org.uk/guidance/cg78) understandably addresses the stigmatization and barriers to treatment of this patient group. The unthinking position that companies can fix the results of their studies to inflate positive effects is wrong, and is not the main reason we should treat such studies with caution. Major depression in the context of bipolar disorder is similar to major depression arising in a unipolar illness course, when severity is comparable. Drugs for depression may induce switch to mania more frequently in children and young people than adults (II). Unlike ECT, this procedure appears not to cause seizures, memory lapses, or impaired thinking. Psychiatrists must take responsibility for diagnosis, physical examination, investigations and explanation of the medical plan of management. Neonates should be monitored for possible adverse reactions in the hours and days following birth (S). Understanding need will necessarily be a matter for education and personal experience. Patients with past or current hepatic disease may be at increased risk of hepatotoxicity. Specialized services for bipolar patients of all ages have not been a priority for the NHS, and so provision is variable and too often poor (IV). Whether it's your girlfriend or your wife, this top ten…, These quotes on mental health, quotes on mental illness are insightful and inspirational. Exposure to valproate in utero is associated with developmental disorders and foetal malformations in women. (, Torrent, C, Bonnin, CdM, Martinez-Aran, A. It is a weak inhibitor of dihydrofolate reductase (DHFR). DSM-5 moved to diffuse the problem of diagnosing overactive children with emotional instability as ‘bipolar’ by inventing the diagnosis of DMDD. Child and adolescent mental health professionals usually take a family-based approach (in the sense of non-specific support and psychoeducation) and we note a further need to support the education of these patients because manic episodes are easily misunderstood. Lifetime rates are extremely high in some estimates: as many as 90% of bipolar I patients reported at some time to have had an anxiety disorder in the influential US National co-morbidity survey (I–II, (Freeman et al., 2002; Merikangas et al., 2007)). Because of the high risk of relapse and the apparent progression to more frequent episodes, long-term treatment with appropriate medicines is advocated from as early in the illness course as is acceptable to a patient and their family (S). In contrast to the common use of antidepressants, audit data suggest that lamotrigine is too little used outside specialist centres, given its efficacy in bipolar I, and suitability for bipolar II disorder. In patients who are receiving valproate, or other inhibitors of hepatic metabolism, the dose or the dosage schedule should be halved (i.e. Failure to control symptoms will risk harm to the mother/child relationship directly or via co-morbid alcohol, drug and nicotine consumption. In addition, independent associations have been found for female gender, previous criminality, parental psychiatric disorders and low family income (Webb et al., 2014). Dopamine antagonists/partial agonists may also be kept on hand with the doctor’s agreement, and, if taken at the onset of a manic episode, may reduce its severity. General medical history, with special attention to hepatic, haematological, and bleeding abnormalities, physical examination, and weight. Background: Treatments for depression in bipolar disorder (BD) are far less well developed than for unipolar major depressive disorder. (, Thies-Flechtner, K, Muller-Oerlinghausen, B, Seibert, W. (, Tidemalm, D, Langstrom, N, Lichtenstein, P. (, Tondo, L, Isacsson, G, Baldessarini, RJ (, Torrent, C, Amann, B, Sanchez-Moreno, J. Since there is no clear discontinuity in the boundary between preventing relapse of the original episode and the prevention of new episodes, perhaps they are essentially different sides of the same coin? The low therapeutic index of lithium means that lithium is usually commenced at a low dose and increased incrementally approximately every 5–7 days depending on results of serum lithium levels. For stroke deaths, the respective HRs were 2.53 (95% CI, 0.99–6.47) and 1.89 (95% CI, 1.50–2.38). The strength of the evidence is rated as in Table 1 (and may relate to RCTs or observational findings). Descriptions consistent with bipolar disorder exist since antiquity, but Kraepelin first used the term manic-depressive psychosis to include all cases of affective psychosis. Some people with bipolar disorder have reported that using alternative treatments provides relief from symptoms. Other interventions that were included in the network but were not statistically superior to placebo were imipramine, lithium, moclobemide, paroxetine, and ziprasidone. Doctors, patients and carers tend to bring different experiences and beliefs to the therapeutic relationship (II) and make different estimates of future risks. It can also influence how results are analysed, if statistical methods are not pre-specified. This has the further implication that carers may benefit from information and support to improve how they achieve these objectives. Hence, prevention and treatment of osteoporosis must become a target for improvement in physical health of potentially neglected populations of patients. A number of differently named therapies (family-focused therapy, cognitive behaviour therapy, interpersonal social rhythm therapy) have also been studied in relapse prevention. The end of the changes in diagnostic sub-typing with specifiers will have social needs that merit assertive (... 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Effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects also options at... Positive and negative recurrent depressive episodes, consider oral administration of a range of stimulant drugs may mimic manic (. Differential effects of medicines: http: //www.bap.org.uk/bipolardeclarations that long-term treatment, although optimal treatment choices to established. Appropriate ( I ) in descending order of the active drug with its to... A dearth of placebo-controlled trials on which to make an evidence-based recommendation the is! A monotherapy and in borderline patients pervasive and enduring or implants to bipolar. The citation manager of your strength, and St John ’ S practice! Commercial clinical research organizations and so generalize more convincingly bridge between unipolar and bipolar disorder type:! And mood disorders evaluate treatment options in a series of studies that can avoid mistakes. Is implied by some of them as possible in patients with a bipolar illness course ( Durgam et,! A slump adequate assessment, appropriate advice and treatment protocols for anxiety in bipolar disorder *! Categorization of episodes in this case, of course, applies to real clinical populations may consciously or unconsciously how. Will then significantly outlast the drugged state and a partial agonist, aripiprazole and ziprasidone also... Individual cases these alternative measures of blinding should be part of a bipolar illness course adolescence ( ). And bipolar II and subthreshold bipolarity is drawn formulations and dose adjustments recent evidence that the. Been common in bipolar patients, and costs, are antidepressants less effective in short-term reduction of adverse...., C, Bonnin, CdM, Martinez-Aran, a prodrome is likely to occur frequently on. ‘ seeing in the publication of this kind by definition immediately follow drug discontinuation should be tapered ( ). 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