Why today’s depression trials demand smart new approaches

2020 was a year of uncertainty, driven by the global pandemic and its enforced isolation and loss of personal connections to loved ones. The world has unfortunately also seen a steady rise in the number of people experiencing some form of depression. Over two-thirds of people who have experienced mental health problems prior to the pandemic have said their mental health has worsened during lockdown, with symptoms resurfacing with renewed frequency and intensity. A recent US study also identified that COVID-19 virus infection may have a direct link to increased risk of mental illness. This may even be the case for people who have never had a mental illness diagnosis.

So where does that leave us? On the one hand, the increasing attention on mental health as a result of the pandemic can go a long way towards addressing existing stigma. However, we also know that many people living with depression have no adequate treatment options; up to a third of people living with depression do not respond to current treatments.

Now more than ever, we need to think about how we can work more closely with those living with mental illnesses, such as depression, to pioneer new solutions. We need to reverse the status quo and find new – and creative – ways to help. To date, participation in hospital-based clinical trials has been the norm for the rigorous development process of new treatments. Now, the use of digital technology has the potential to be a game changer by enabling decentralized clinical trials (DCTs) to overcome geographic and other barriers.

First of its kind decentralized clinical trial (DCT) in depression

We have recently applied a DCT model for a new phase II clinical trial in major depressive disorder (MDD) in the US. The trial explores a potential new treatment for emotion processing, a common symptom of depression. Our hope is that this first-of-its-kind DCT in depression will foster enrollment across a more representative cross-section of people living with the condition. In turn, we will gain more accurate insights into the potential benefits of this investigational treatment, without compromising on rigor or effectiveness in our clinical trial protocols.

There are multiple types of DCTs. In our DCT trial, participants engage in outcome assessments with a mobile nurse from the privacy of their homes. The DCT will incorporate multiple digital health technologies (e.g. telemedicine, mobile apps, smartphone) which can reduce some of the burdens associated with traditional research. This expands the access and opportunity of participation to a broader portion of patients with depression. In this trial, the mobile nurse provides training on specific administration of the investigational medicine and explains how to connect with the trial investigators if questions arise.

Championing the needs of people with depression

Our depression research does not stop with this DCT. ‘Disturbed emotional processing’ is the target for another of our phase II depression clinical trials. By applying our ‘circuit to symptom’ methodology, we will be investigating a novel compound combined with digital applications, including a medication adherence monitoring platform. Applying our precision psychiatry approach, we aim to explore the potential impact of our therapy on emotional processing for people with depression. We are especially keen to see if this helps people who do not respond well to current antidepressant treatments.

Personal connections are vital to our human experiences and that is why our goal is to find solutions for patients that can help improve their quality of life and reignite their own personal connections. We recognize the urgent clinical need to find new options and at Boehringer Ingelheim, we are more determined than ever to address this unmet need through our precision psychiatry approach. By leveraging smart technological clinical trial design, in combination with our pharmacological research, our hope is to implement more diverse and effective trials that provide a more accurate picture of the potential benefits of our investigational therapies. Through collaboration with patients, these therapies may one day make a meaningful difference in the lives of people living with depression.

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