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By Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC

Mental illness has been on the rise at an alarming rate over the last few years, even before the Covid-19 pandemic. Nineteen percent of adults in the U.S. experienced a mental illness in the 2017-2018 calendar year, an increase of 1.5 million people compared to the previous year’s dataset, according to Mental Health America’s latest annual report of the state of mental health in America.1

SMIs: What are they?

The burden of mental illness is particularly pronounced for those with a Serious Mental Illness (SMI), a category defined by the National Institute of Mental Health (NIMH) as a severe mental, behavioral, or emotional disorder resulting in serious functional impairment, which substantially interferes with or limits one or more major life activities.2 SMIs produce severe hardship for millions of families, costing these Americans approximately $193 billion in lost earnings annually.3

Major depressive disorder, also called major depression, is a SMI and is the leading cause of disability in U.S. adults.4,5 What’s more, nearly a third of people living with major depression are considered treatment-resistant, meaning they have cycled through at least two different antidepressants without achieving adequate symptom relief.6 This serious level of depression is not just debilitating; it can be deadly, as those with major depression are at an increased risk for suicide, which underscores how important it is for effective interventions to be accessible to those who need them.

The need for better depression treatments

While research into other disease states has led to extensive development of pharmacologic treatment options in recent decades, advancements in depression treatment have been modest. Today, depression is one of the most underfunded conditions by the U.S. National Institutes of Health, when viewed through the lens of disability and healthcare burden in the U.S.7 Additional funding for depression research could help accelerate advancements in the field, but funding alone is not sufficient without a concerted effort by pharmaceutical companies to innovate.

Barriers to innovation in the mental health space

Unfortunately, many large pharmaceutical companies have moved away from innovation in the mental health space for a few reasons:

  • The high failure rate of clinical trials in mental health. Approximately 50 percent of antidepressant trials fail to show statistically significant effect,8 and drug failure rates for new medications are in the 90-plus percentage range. The failure rate is even higher in complex neuropsychiatric conditions like major depressive disorder.9
  • There’s still a vague understanding of how the brain works. While there have been advances in understanding and treating brain disorders, the ability to translate this understanding into novel therapeutic treatments and technologies remains elusive.
  • It’s difficult to find treatments for a large portion of the affected population. Because some people do not respond well to certain depression treatments, it’s a significant challenge to develop medications or treatments that will adequately meet the needs of a significant number of people in this population.

How to overcome these barriers

At Janssen, we are working hard to overcome these challenges. Where neuroscience was once an observational science, our increased understanding of biological pathways and neuro-immunological processes is helping it transform into a data-driven discipline. This is especially true for mood disorders (like depression) in which new tools are improving our ability to detect, understand, and monitor SMIs.

These insights provide us windows of understanding into disease and wellness that were unimaginable a decade ago.

For example, we’re now able to use non-invasive imaging to look at how different parts of the brain are connected and observe altered patterns of connectivity to disease states. We’re also building digital tools that will enable doctors to continuously monitor their patients, which may help clinicians better and more quickly understand their needs, enable earlier interventions, and potentially alter the course of disease.

Effectively bringing these types of digital tools to market may reduce hospitalizations and overall costs to the healthcare system as well. More importantly, using digital outputs to improve the way we measure clinical outcomes can potentially reduce and prevent a relapse for those with mental illnesses.

Improvements to the way we design clinical trials are also helping Janssen advance care in the depression space. Despite the high clinical trial fail rate in depression, Janssen has demonstrated our commitment to bringing new and innovative products to market. We do so by conducting clinical trials with thousands of patient participants around the world.

What’s next for the industry?

While this innovation is hopeful and promising, our track record in bringing new treatments as an industry needs to be better. Thirty years ago, George H. W. Bush designated 1990 – 1999 as the Decade of the Brain to “enhance public awareness of the benefits to be derived from brain research.”10 While the creation and application of knowledge during the ensuing decades have led to a renewed promise in neuroscience, progress has not been as rapid as patients need.

Over this next decade, we at Janssen intend to move from a pipeline of promise to a pipeline of products that enhance overall health and wellness. Please, join us in putting a greater focus on depression research and treatment advances. We hope that our work is helping to pave the way as we come together as an industry to bring solutions to those most severely impacted by mental illness.


1 Mental Health America. The State of Mental Health in America. Accessed February 8, 2021.
2 National Institute of Mental Health. Mental Illness. Accessed February 8, 2021.
3 National Institutes of Health. Mental Disorders Cost Society Billions in Unearned Income. Available at: Accessed February 8, 2021.
4 Agency for Healthcare Research and Quality. Disparities Within Serious Mental Illness. Accessed February 8, 2021.
5 World Health Organization. Depression. Accessed February 8, 2021.
6 Rush et al. Am J Psychiatry. 2006; 163:1905-1917.
7 Gillum LA et al. PLoS One. 2011;6(2):e16837.
8 Kirsch I. Z Psychol. 2014;222(3):128–134.
9 Hingorani AD, Kuan V, Finan C, et al. Nat Rev Drug Discov. 2019;9 (18911).
10 Goldstein M. West J Med. 1994;161(3):239–241.