A NEW, NON-DRUG APPROACH TO TREATING DEPRESSION.

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1 A NEW, NON-DRUG APPROACH TO TREATING DEPRESSION

2 2 Depression A large and growing challenge in society Numerous studies over the past decade have revealed the true extent and devastating impact of depression. Depression not only affects the individual, but also their families, health service providers and communities and even national and global economies. Experiences of depression are not limited to a tiny minority of the population. Large, multinational epidemiological studies have indicated that approximately 16% of a population experience depression and anxiety over a lifetime; the World Health Organization (WHO) projects that depression will become the leading cause of disease burden, globally, by The fact that depression poses a significant economic burden to Europe was shown in a peer reviewed article in In 28 European countries with a population of 466 million, at least 21 million people were found to be affected by depression. The total annual cost of depression in Europe was estimated at 118bn or 253 per inhabitant. Direct costs totalled 42bn, comprising of 22bn for outpatient care, 9bn for the cost of drugs and 10bn for hospitalisation. Indirect costs due to morbidity and mortality were estimated at 76bn. According to these figures, depression is the most costly brain disorder in Europe, and represents at least the equivalent of 1% of total European GDP. In England, a King s Fund review estimated that there were 1.24 million people with depression, with 2007 estimated total costs including medical, social services and workplace absenteeism of 1.7bn, whilst lost employment increased the total to 7.5bn. The review projected the number of people with depression to grow by 17% to 1.45 million by 2026, with costs rising to 3bn and 12.2bn, respectively. The effect on lost employment and productivity has been found to be 23 times larger than the costs falling to the health service. Additionally, people suffering depression or anxiety were three times more likely to be absent from work. Such findings are perhaps just the tip of the iceberg in terms of the hidden costs of depression. For the tax year 2009/10, the financial cost of depression in the UK was recently estimated at approximately 150bn, of which 30bn was thought to be work related. Overall, the indirect costs of depression far outweigh direct and health service costs. With the costs of depression projected to rise, it is important that healthcare spending is used to maximise the treatment benefits for people with depression.

3 Current standard treatments leave a significant unmet need 3 Of the population receiving treatment for depression, a large proportion is not responding adequately to current treatment approaches, with an estimated 50-70% described as treatment resistant. First line treatments currently include psychotherapy or pharmacotherapy with remission the ultimate goal. However, remission is achieved in less than one-third of pharmaceutically treated patients, and a treatment response achieved in only half of patients. Ultimately, around one-third of patients with major depression are medication-resistant. Physicians face many challenges in the treatment of major depression by antidepressants. Slow onset of action means that most antidepressants require at least two to four weeks before any improvement in symptoms, but remission may take considerably longer. Another challenge is the poor response to antidepressants, a recent meta-analysis revealed a treatment response rate of 53.8%, compared with 37.3% seen with placebo. In the real world, these results suggest six patients would need to be treated to see one additional response not due to chance alone. Remission rates are even lower, ranging from 30% to 35%. Additionally, the chance of achieving remission declines with each failed treatment. Non-adherence is another treatment challenge, with an estimated 40% of patients self-discontinuing antidepressants within 90 days of a prescription. A major reason is the side effects of medication. Depending on the drug and mode of action, adverse side effects include: cardiovascular, such as hypertension, arrhythmias or hypertensive crises; neurologic side effects such as headache or seizures; gastrointestinal discomfort; sexual dysfunction; weight gain; sedation or insomnia. Considering the number of antidepressant drugs and variety of side effects, it is not surprising it is challenging for a physician to find a drug with a benign side effect profile while still having a treatment effect for each individual patient. Again, it is worth repeating that it may take months for a treatment response and the chance of achieving remission declines with each failed trial. The role of ECT Seizure-inducing electroconvulsive therapy (ECT) has been established as a safe and effective method of treatment for severe depression. However, ECT is generally only recommended for patients who cannot tolerate antidepressants, those whose depression has not responded to other treatments, or those who require a rapid response. Although ECT can be safely administered, with generally favourable results, it is nevertheless associated with reversible but disturbing adverse neurocognitive effects, such as memory loss. In addition it is an in-hospital treatment with the risks associated with anaesthesia.

4 4 The rational for gentle brain stimulation therapy: TMS The human brain is essentially an electro-chemical organ, in which electricity triggers the release of neurotransmitters that then trigger a cascade of electrical activity. Apart from certain reflexive actions of the body, all functions and behaviour are initiated in the brain and have an electro-chemical origin, including motor movement, thoughts and emotions, as well as psychological dysfunction. It should then not be so surprising that neuromodulation the use of electrical signals to alter brain function can play a role in treating depression a brain dysfunction. The idea of using electromagnetism to alter brain and neural function goes back to at least the early 1900s, although the era of modern transcranial magnetic stimulation (TMS) began in 1985 when researchers constructed a focal electromagnetic device with sufficient power to stimulate the human brain. TMS is perhaps the most promising of the brain stimulation techniques because it is painless, non-invasive and can be performed in an office setting without side effects. The clinical effects of TMS are produced without the need for seizure induction, as with ECT, or without craniotomy, as with experimental deep brain stimulation. TMS is considered safe with the rare side effect of seizure, a risk that is as low as that associated with the use of antidepressants.

5 5 What are TMS and rtms? TMS uses a focal electromagnetic coil held over the scalp to create a strong but transient magnetic field. The magnetic field passes into the cortex and other upper levels of the brain without interference from the skin, muscle and bone. In the brain, the magnetic pulse induces a weak electrical current to flow in the tissues underneath the coil. Thus, the magnetic field created from electrical energy in the coil passes through the skull and is converted back into electrical energy in the brain an elegant form of electrodeless electrical stimulation. In practice, the phenomenon is complicated by the brain not being a uniform conductor and the effective electric field can be induced quite far from just under the coil. However, navigation and field-modelling techniques developed by Nexstim for neurosurgery fully account for these effects. When TMS is strong enough to activate neurons in the brain, the activated neurons will, in turn, affect other neurons, thereby propagating the stimulated activation within brain circuits and along neuronal pathways to other parts of the brain. Depending on the area activated, stimulation can be propagated to the periphery, inducing movement in the limbs, for example. The strength of the field needed to stimulate neurons varies by individual, but can be determined by measuring the patient s own resting motor threshold the field strength needed to just measure a response in the hand. Repetitive TMS (rtms) is the repeated application of TMS pulses. Whether TMS is repeated at a fast or slow rate has completely contrasting effects: rapid-rate rtms excites the underlying neurons while slow rtms inhibits the underlying neurons. It is rapid-rate rtms that is employed in depression therapy. Graphic showing how the brief electric current (green) in a TMS coil generates a magnetic field (blue) directed into the brain. The magnetic field induces a corresponding weak electric current in the underlying neurons of the cortex, resulting in their activation and depolarization.

6 How rtms works in depression therapy In therapy for depression, rtms is used to excite targeted brain areas and modify their function. Certain brain regions have been consistently implicated in the pathogenesis of depression and mood regulation: these include the medial and the dorsolateral prefrontal cortex (DLPFC), the cingulate gyrus, and other regions commonly referred to as limbic. The DLPFC has been most commonly implicated since the region typically shows abnormal electrical activity and decreased blood flow in depressed patients. In current treatment paradigms, the stimulation coil is therefore placed over the frontal part of the head to aim the magnetic pulses into the DLPFC. Electric fields induced in the DLPFC cause activation and depolarisation of neurons. The release of neurotransmitters spreads the activation throughout the brain s limbic system. rtms has been described as a kind of focal pharmacology when compared to using systemic antidepressants. A typical therapy session lasts about 50 minutes, comprising about 3,000 stimulations. Treatment is well-tolerated; patients might feel their facial muscles contract at the time of treatment and some may have a mild headache afterwards, but there is no deterioration in memory or cognition. Stimulation is typically prescribed as a course of five sessions per week, for a period of four to six weeks. In addition to location, stimulation intensity, frequency and duration, also brain atrophy, gyral anatomy and nerve fibre orientation relative to the coil all influence the effectiveness of rtms, and should be taken into account, requiring MRI-based targeting and navigation of the stimulating field. However, despite the limitations of first-generation equipment used, rtms has already been shown to be effective in the treatment of depression. In several large clinical trials where stimulation has been aimed at the DLFPC without navigation, rtms has proven to be effective with approximately 50% of major depression patients responding significantly to treatment and 15-37% of patients sustaining total absence of depression symptoms. These results are similar to the best achieved by antidepressants, but without the side effects associated with systemic drugs. Based on these results the first rtms device was cleared by the US Food and Drug Administration (FDA) for the treatment of depression in When rtms therapy has been effective, durability appears to be at least as long as with other treatments. Without the side effects of medication, rtms is being seen as potentially the preferred treatment choice, for example in the treatment of post-natal depression. In the USA, the Practice Guideline for the Treatment of Major Depressive Disorder (American Psychiatric Association) currently recommends rtms as a second line treatment alternative, when first line treatments, including pharmacotherapy or psychotherapy, have failed to show improvement in symptoms. In the EU, practice guidelines vary, and in several countries the use of rtms in the treatment of depression is under review. 6

7 Navigated Brain Therapy (NBT) Navigation offers the ability to locate the structures in the brain associated with depression and target stimulation in an uniquely accurate and controlled manner. Having an MRI scan available allows for a trained physician to locate the DLPFC region in the brain and account for any individual variations or atrophy. In Nexstim s Navigated Brain Therapy (NBT), navigation is based on seeing inside the head using the data from the MRI scan to make a 3D rendering reconstruction of the brain and modelling the conductivity of the brain to see the real location of the stimulating field in the 3D rendering. As mentioned earlier, brain atrophy, gyral anatomy and nerve fibre orientation relative to the coil all need to be taken into account. Importantly, in every therapy session a patient receives, the position of the coil relative to the brain should be the same something that is achieved automatically by navigation, but very hard to achieve otherwise. With NBT, once the therapy target has been found, the NBT System stores the spatial coordinates and ensures that in all subsequent sessions stimulation is repeated at exactly the same location, with the same rotation angle and tilt for the coil. The importance of navigation was shown in a study where rtms applied by skull landmarks resulted in significantly less effectiveness (measured on the Montgomery-Åsberg NBT uses MRI to guide rtms therapy Depression Rating Scale) than when navigation was employed. The navigation and field-modelling techniques used by NBT have already been cleared by the FDA for use in neurosurgical planning and have been proven to be accurate in hundreds of the most demanding brain surgeries. NBT is the first technique to remove the basic sources of error in rtms therapy for depression. Nexstim s NBT also allows the stimulation intensity of rtms treatment to be quantified and optimised according to the patient s individual brain anatomy. Optimising intensity allows for a more comfortable experience and better compliance while ensuring effectiveness. Optimising the stimulation intensity requires knowing the patient s motor threshold (MT), since that tells the excitability of the individual patient s brain. With NBT, navigation ensures that MT is measured from the correct location inside the brain, and the response is accurately measured and quantified from an EMG. Hence, NBT allows treatment to be personalised to accurately and comfortably target stimulation therapy to the brain. Patient comfort and the perception that stimulation therapy is a pleasant experience are particularly important since the therapy effect is dependent on the patient willingly returning to complete the prescribed course of treatment. Treatment for depression with NBT is an outpatient procedure. Once the preparatory steps for navigation have been made, a therapy session lasts for about 50 minutes. With no side effects, the patient is free to continue with daily activities after a session. 7

8 Working it out Yves Brand and Silvana Enculescu, of Mental Health Europe, urge the EU to take up a method of individual placement and support for young people with mental health issues A young person with mental health problems, who likely suffers from multiple disadvantages, needs the inclusive labour market mechanisms and access to quality services to be jointly implemented, believe Brand and Enculescu 8 Young people born in the late 1980s and early 1990s may well be entitled to complain they were dealt a bad hand. Born in an era of technological development and developing liberties, the Millennials could have been starting out their working lives full of optimism, had it not been for the financial crisis. However, they are now called the Lost Generation, one that has to deal with unprecedented unemployment and economic instability. Young and jobless Constantly increasing, the youth unemployment rate across the EU has now reached a staggering 20.9%, up from 9.6% in Unfortunately, unemployment also closely correlates with mental health problems, with almost half of unemployed young people believing joblessness to have caused them panic attacks or insomnia, and more than 41% of young people not in Education, Employment, or Training (NEETs) claiming to have felt suicidal. Attesting to a vicious circle, the employment rate for people with mild and moderate mental health problems is at least 10-15% lower than that of the general population. The situation is even worse for young people with more severe mental health problems, who remain very unlikely to find and keep meaningful, paid employment, although this could greatly aid their recovery and substantially reduce the costs of their care and treatment in the longer term. While the average employment rate for the UK was 74.2% between August and October 2008, only 22% of the respondents to the 2008 Healthcare Commission survey of people using mental health services said that they either had paid work or were in fulltime education. Moreover, the length of the period persons with mental health problems stay unemployed is a severe problem. In all countries where data was available, people with mental health problems were almost twice as likely to be long-term unemployed as those without mental health problems. This is problematic, as data shows those who enter the disability benefits system due to unemployment are unlikely to leave it. Currently, at least one-third of all new disability benefits claims come as a result of mental health problems, a figure that goes up to over 70% in the young adult population. Tried and tested However bleak, the chances of employment for young people with mental health problems are not unchangeable. A vast majority wants to and can work with the right help, and although barriers to employment do exist for young people with mental health problems, these do not necessarily relate to the severity of their conditions. Actually, regardless of the diagnosis, willingness to work and believing that you can are the best predictors of work outcomes, and studies show that between 70% and 90% of persons with mental health problems wish to gain employment or return to work. Therefore, it is now time for governments and EU institutions to demonstrate the same will to support

9 them in their search for work and in recovery. International experience and research has shown that, with the right kind of support, even young people with severe mental health problems can secure and maintain paid competitive employment. More than 16 randomised, controlled trials and a Cochrane Review have proved that Individual Placement and Support (IPS) is by far the most effective methodology. The IPS method is a place and train technique, emphasising rapid job search and placement, and offering unlimitedtime support to both employer and employee. It focuses on the individual looking for paid employment, prompting health and employment services to work together with potential employers to achieve a perfect job match for the client. Employment specialists are therefore integrated and preferably co-located within clinical teams, and employment becomes a goal of the mental health services. Research has shown that IPS has a success rate more than double that of traditional train and place vocational rehabilitation services, and there is also good evidence to suggest that with IPS these success rates hold up even when jobs are scarce. A shift in consciousness While most EU member states do have active inclusion strategies among their priorities and policies, these are not wellintegrated. A young person with mental health problems, who likely suffers from multiple disadvantages, needs the inclusive labour market mechanisms and the access to quality services to be jointly implemented. Single-targeted policies will not work in this context. The health system must also focus on both clinical and employment outcomes, and should provide services to tackle both aspects. It is well-known that being in employment can play a vital role in recovery for many people with mental health problems. Moreover, while widely used, traditional work schemes such as protected and sheltered workplaces reflect an institutional and very inefficient way of tackling the employment of persons with mental health problems, and may even be an obstacle to open employment a goal for most people. Sheltered settings work on the assumption that people who developed skills and confidence in a protected area would then move on to open employment. However, there are indications that such schemes often succeed only in convincing individuals that they are incapable of working outside a sheltered environment. Such schemes could therefore actually add to the individual and structural barriers to employment low motivation and confidence, side effects of medication, fear of losing welfare benefits, employers attitudes, perceived stigma and discrimination, and healthcare professionals low expectations that young people with mental health problems already face. Taking a totally different approach, IPS works with the individual to find a match between his or her strengths and a paid job in the competitive labour market. The client has access to psychiatrists, psychologists, nurses, social workers, occupational therapists and other care providers. All staff within the clinical team collaborate to provide optimal support in addressing the client s health and social care needs, including retaining or gaining employment, and other vocational needs. Most importantly, each case is treated on an individual basis, and all support is personalised. There are no exclusion criteria, anyone who wants a job can join the programme, and the job search is tailored to the individual s needs and preferences. Moreover, the support is not limited to any set amount of time, is ongoing, and can be provided to both the employer and the employee. Not just a crisis approach It is easy to blame the huge unemployment rate among young people with mental health problems on the financial crisis, but, sadly, this problem existed before it, and will likely exist after. There is still massive prejudice among key actors in the labour market towards persons with mental health problems, and this needs to be urgently addressed. Data revealed that although employers would be motivated to hire a person with mental health problems, access to the necessary support and interventions was a major challenge. Also, the misconception that hiring people with mental health problems would incur substantial costs was still widespread. Mental Health Europe (MHE) believes there is every good reason to invest in giving young people with mental health problems a chance of obtaining employment, in line with their skills and objectives. Success is not just good for the individual, but also for the economy, with savings from higher tax-take, lower out-of-work benefits and reduced healthcare costs in the longer term. The European Commission should therefore focus on IPS as a good practice for employment and should invest in it through EU funding instruments. MHE also calls on member states who do not yet use the method to implement it. For the Lost Generation, solutions can be found, and governments need to make it a priority to make sure this indeed happens. Yves Brand Policy Officer Silvana Enculescu Communications Manager Mental Health Europe 9 Tel: info@mhe-sme.org

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