Rising burden of disease

Depressive disorders are among the most prevalent conditions globally and the associated burden of disease is growing. For many people these are life-altering, chronic conditions which not only affect every aspect of their daily lives but can also have considerable impact on their loved ones.

The WHO estimates the global impact of depressive disorders at 57m Disability-adjusted life years (DALYs) in 2021, putting them in 13^th place, up from 37m DALYs and rank 19 in 2000.¹ In part at least this increase is associated with the COVID-19 pandemic - according to the WHO, the number of people suffering from depression and anxiety went up by 25% in the first year of the pandemic alone².

Global spending on mental health medication is also expected to increase in the next years. The figure currently stands at 81bn USD, with a projected 9-12% CAGR until 2028, exceeding the projected total market growth of 5-8%³. There is also considerable potential for future innovative therapies: although trial starts in 2023 were below the pre-pandemic level, there are currently nearly 250 ongoing trials covering a wide range of MoAs⁴.

However, pharmaceutical treatment is only part of the picture in managing Major Depressive Disorder (MDD). People affected by MDD also benefit from psychotherapy and supportive complementary treatments like meditation or sports to improve overall well-being. Support programmes for patients with a focus on self-efficacy and reducing self-stigma can also be helpful. Overall, though, there is still considerable unmet need.

IQVIA partnered with patient organisation MQ Mental Health Research to conduct a survey of people living with MDD to discover which difficulties they encounter in the course of diagnosis, treatment, and adjusting to living with the disease and where they could benefit from additional support. The survey consisted of in-depth interviews with six participants with moderately severe to severe MDD based in the UK, the US, and Spain.

The information provided in these interviews reflects both the pervasive impact of MDD and the considerable unmet needs in treating and managing it.

Unmet clinical need drives motivation to participate in clinical trials

With regard to pharmaceutical treatment, patients report that finding a helpful pharmaceutical regime is challenging since it often involves a combination of drugs, for instance anti-depressants combined with anti-anxiety medication. They are also often unhappy with the side effects of antidepressants which they describe as “numbing” or making them feel “like a zombie” but do not restore the lost feeling of well-being or the ability to function in day-to-day life. In addition, the medication is not effective immediately but takes some time to build up which can make it difficult to disentangle which changes in a patient’s condition are the result of medication or of other interventions.

Psychotherapy is perceived as helpful, but people often experience barriers to access – sometimes other doctors do not want to refer the patient, there may be no therapists available in a reasonable timeframe, or psychotherapy is not covered by the patient’s insurance. It can also take time to build up trust and sometimes several tries to find a therapist with whom the patient feels comfortable.

The lack of efficacious pharmaceuticals experienced by the patients IQVIA spoke to drives a willingness to participate in clinical studies provided certain conditions are met. For these patients, the prospect of getting early access to new therapies which might improve their overall condition is a key reason to consider clinical trials. It is however imperative that potential participants feel well informed and well taken care of. Information needs to centre around understanding the medication being tested, what possible side effects there are and the potential outcomes. Information about the logistics of the trial and what is being expected of the participants is also essential. It is important that this information is delivered by the participants’ own HCP or by clinical trial staff in a sensitive, empathic manner, with enough time taken to answer questions. Booklets for follow-up are also valuable.

In designing clinical trials, the severe impact of MDD on people’s executive function must be taken into account. Issues such as fatigue, brain fog, lack of motivation and organisation, social anxiety and similar topics are very commonly reported. In order to ensure participants’ adherence and compliance, practical and motivational support must be ensured to overcome these barriers.

The motivation for participating in real world studies and for sharing data is somewhat lower than for participating in clinical trials. This is largely due to a lack of understanding of the purpose and value of RWE studies and a reluctance to share confidential and often very personal insights into their emotional and mental state with people they do not know and have no opportunity to establish a trust-based relationship with. The potential benefit of gaining early access to new therapies is also lacking. This reluctance could potentially be overcome by building awareness about the benefit of RWE studies and cultivating relationships with patient communities.

An opening for pharma

There is also an opportunity for pharma to step into the gap where patient support is concerned – interview partners report that they rely primarily on their families and people close to them for practical and psychological support. Further sources are social media and patient support groups where experiences and information can be shared. Pharma, on the other hand, is not perceived as being in the business of supporting patients – “that’s not what they do, is it?”

Given the unmet need reported in terms of information and guidance on managing life with MDD and also the challenges outlined above in informing and motivating patients to participate in clinical trials and share data for RWE studies, there is some potential here for pharma to tap provided they step carefully and focus on building relationships with the patient community based on respect and trust. Building and nurturing such support systems could benefit patients by helping them better understand and manage their condition, and pharma by improving patient compliance and adherence through better expectation management as well as participation in clinical trials and RWE studies.