Blog
Mood disorders and Real-World Evidence: Supporting drug development and improving patient outcomes
Rachel Armstrong, Principal, Real World Solutions, UKI, IQVIA
Saskia Hagenaars, Epidemiologist, IQVIA
Christelle Elia, Consultant, IQVIA
Sophia Fleming, Sr Consultant, Real World Solutions, UKI, IQVIA
Akrivia Health
Oct 10, 2022

Importance of recognizing mental health

10th October is World Mental Health Day; this year’s campaign is centred around “Making Mental Health & Well-Being for All a Global Priority”. Throughout this blog, we will discuss the importance of recognising mental health, touch on the impact of the COVID-19 pandemic, and finally take a closer look at bipolar disorder and depression, discussing how Real-World Evidence can be used to improve knowledge and outcomes for patients.

Prior to the pandemic, it was estimated that 1 in 8 people globally were living with a mental health disorder. During the pandemic, we saw large scale disruption to health systems across the globe exacerbating the already short supply of mental health services and creating a global crisis. Not only were existing services limited, but the WHO estimates that anxiety and depressive disorders increased by 25% globally during the first year of the pandemic, increasing the mental health crisis even further as more people require help and support. By the middle of 2020, one in five people in the UK were suffering from depression, twice the number in 2019, according to data released by the Office for National Statistics (ONS 2021) with women, aged 18-30 years old, people with pre-existing mental or physical health problems, those living in deprived areas, and ethnic minority communities most affected.

Mental health in the UK

While this blog intends to focus on bipolar disorder and depression, there are many other types of mental disorders. Mental disorders are often characterised by clinically significant disturbances in cognition, emotional regulation, or behaviour (WHO), such as but not limited to; anxiety, post-traumatic stress disorder (PTSD) and schizophrenia. In the UK, Mind, the mental health charity, estimate that 1 in 4 people will experience a mental health problem of some kind each year with mixed anxiety and depression being the most common. In any given week, 3 in 100 people will be diagnosed with depression and 2 in 100 people in their lifetime will receive a diagnosis for bipolar disorder. When looking at treatments for mental disorders, potentially as low as 1 in 8 are currently receiving any form of treatment. Mental health problems represent one of the single largest causes of disability in the UK (NHS England). This combined with the low treatment rate and high numbers of people diagnosed with mental health disorders are suggestive of a significant level of unmet need.

What are depression and bipolar disorder?

A depressive episode is very different to the short-lived emotional responses and usual mood fluctuations experienced during the challenges of everyday life. When in a depressive episode, a person not only experiences a depressed mood with feelings of sadness, irritability, emptiness, but also loss of pleasure or any interest in activities, nearly every day for at least two weeks. Alongside the depressed feelings and lack of interest, other symptoms present such as poor concentration, feelings of guilt, low self-worth, thoughts of self-harm, disrupted sleep, and appetite changes. The thoughts and feelings while in a depressive episode can be crippling and lead to an increased risk of suicide (WHO).

In bipolar disorder people experience alternating depressive episodes with periods of manic symptoms. The depressive episodes follow the same pattern and symptoms as depression more generally. Meanwhile manic symptoms are almost opposite in nature with people experiencing euphoria, increased energy, racing thoughts, increased self-esteem, decreased need for sleep, and impulsive reckless behaviour. Similar to depression, bipolar disorder also increases the risk of suicide (WHO).  Bipolar increases an individual’s risk of suicide by up to 20 times (Bipolar UK).

Treatment challenges

Whilst our understanding of these disorders has progressed including our understanding of the pathophysiology, there is still a large unmet need when it comes to finding effective treatment options. Antidepressants are the first line treatment for depression, and a large network meta-analysis showed the beneficial effects over placebo. However, a proportion of depressed patients do not reach remission. The STAR*D study showed that remission rates were lower for each subsequent treatment for depression, with only around 30% of patients responding to the first antidepressant and around two thirds of patients reaching full remission by the end of the study.

Individuals with bipolar disorder suffer from a multifaceted and unpredictable course of their disease characterised by manic or depressive symptoms. Mood stabilisers are the main treatment for bipolar disorder. Despite following treatment, patients are at high relapse risk. In fact, between 40% and 60% of patients with bipolar disorder who are treated with mood stabilisers relapse within 1-2 years with repeated relapses causing a downward spiral in quality of life.

Understanding potential mechanisms of action or treatment pathways that may be effective in preventing or treating both depression and bipolar disorder could help address the unmet need for effective treatment options.

Real World Evidence and Mental Health

The use of real-world data to better understand treatment pathways and unmet need in psychiatry is of growing importance to healthcare systems. The challenge we face in using real world data to address the unmet need in mental health disorders is that the most valuable data in electronic health records exists in psychiatrist notes in the form of unstructured, free-text data, and as such, are typically omitted from most databases (as they typically report only structured data). Whilst the structured data can provide real quantitative insights and projections, the richness of the unstructured data can provide context and valuable insights to a patient’s condition and quality of life and allows tailoring interventions to patient’s specific needs, therefore optimising the outcomes. Using structured data, we can define cases and controls based on the number of diagnostic codes they have for a certain disorder in combination with prescriptions of certain medications, or by excluding certain diagnostic codes due the overlap with the disease of interest (such as with depression and anxiety). The disadvantage is that there would be a risk of misclassification due to the diagnostic codes primarily being used for billing purposes rather than research purposes or due to differences in coding practices. However, when incorporating the unstructured data, one can use symptom level and outcomes related data to enhance the phenotypic precision. It has been shown that incorporating unstructured data significantly improves the accuracy of case detection above and beyond coded data alone. Most of the research using unstructured data has been done in US based hospital EMR databases.

To address this challenge within the UK, IQVIA is partnering with Akrivia Health, the world’s largest and most in-depth dataset focused on mental health to enhance real world evidence generation. Using artificial intelligence and natural language processing, we can access de-identified patient data containing end-to-end clinical pathways and cover each interaction and intervention that takes place between a patient and their clinician. Information is sourced from multiple Electronic Patient Records and comprises clinical notes patient histories, admission and discharge documents and clinical assessments.

By partnering with Akrivia Health to leverage their unique mental health dataset, IQVIA can use real world data to add value to every stage of the drug development and commercialization lifecycle to enable our customers to accelerate research within the mental health setting.

For more information, contact Rachel Armstrong: Rachel.armstrong@iqvia.com or Akrivia Health: Contact@akriviahealth.com

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