Medical diagnostics for most human illnesses rely on measurable, objective data, such as blood tests or imaging scans.

Diagnoses for psychiatric conditions, however, have mostly been based on symptoms and subjective patient reporting. Overlapping symptoms among different conditions and inherent problems with self-reports can delay or — even worse — confound a mental health diagnosis, hindering clinicians’ efforts to provide the most effective treatment.

Bringing the concept of precision medicine to psychiatry could change all of that, improving diagnosis and therapeutics for patients, especially through the use of genetic or molecular testing. Although interest in precision psychiatry has grown in recent years, finding the right path forward has been challenging.

The recently proposed Precision Psychiatry Roadmap could lead the way.

Conceptualized by an international group of clinicians, academics, and representatives from medical organizations, regulatory agencies, and industry, the roadmap lays out plans for a practice-changing, biology-informed diagnostic classification system for mental disorders, which experts say could bring precision medicine to the field of psychiatry in about 15 years.

“There is a high unmet need, especially in mental disorders, for effective treatments. And we think now is the time that we can do better because technology is rising, we have better access to the brain, and we’re using better imaging approaches,” Martien J.H. Kas, PhD, a professor of behavioral neuroscience at the University of Groningen, Groningen, the Netherlands, and president of the European College of Neuropsychopharmacology (ECNP), told Medscape Medical News.

Kas and the ECNP spearheaded the roadmap project, which was published online recently in Molecular Psychiatry.

“The journey has already started,” Kas said. “We now have to work very hard to actually implement the framework.”

Trial and Error

Diagnosing psychiatric illness without objective measures is difficult, even with clinician expertise, Leanne Williams, PhD, professor of psychiatry and director of the Stanford Center for Precision Mental Health and Wellness, Stanford University, Palo Alto, California, and author of the book Precision Psychiatry, told Medscape Medical News.

“It’s primarily a trial and error process right now,” Williams said.

One of the project’s main objectives is “to align research efforts to work toward integrating symptomatic, biological, and behavioral information into the definition of mental disorders to advance the development of effective treatments,” Kas and colleagues wrote in the recently published article. This could include the integration of blood tests, MRIs, and even smartphone feedback.

Adding in biomarkers has the potential to help with all psychiatric conditions “because they all have some relationship to the brain and how it links to our behaviors and to other systems in our body,” added Williams, who is a member of a steering committee that oversees and initiates activities centered around the roadmap project.

Williams was a keynote speaker at ECNP New Frontiers Meeting 2024, where the roadmap initiative was launched.

“I think the roadmap committee is doing a really good job of getting that global perspective, and there’s also good US representation there,” she said.

Williams noted that initial impact from the new framework will probably be for conditions with the most data, such as depression, but added that there has also been progress in research for schizophrenia and posttraumatic stress disorder.

Building Consensus

The proposed roadmap lists three main components, the first of which is to develop a global alignment of principles and procedures in the field for moving forward with a new diagnostic framework.

“We appreciate the many [diagnostic] initiatives out there, but think it is better to align on the way to progressing science together, with similar definitions and, ideally, similar tools,” Kas said.

The second component is to reach consensus on the predictive validity of biological measures based on emerging data. This would include conducting clinical trials and obtaining regulatory approval for biomarkers and treatments.

Finally, the roadmap outlines a way for the field to incorporate the latest biological data into diagnostic classification and treatment guidelines for use in clinical practice. This likely would include involvement from such organizations as the American Psychiatric Association (APA) and the World Health Organization.

“What we are doing at the moment is setting up and conducting all kinds of consensus meetings, we’re disseminating information through publishing, and we’re discussing ways to reach out to and inform the community,” Kas said.

One way is through a “knowledge hub” on the ECNP website, he noted, which stores various information, including details about the roadmap.

A Living Document

Collaboration is also important with organizers of the next iterations of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases, project leaders said.

In fact, some members of the project steering committee are also members of APA committees working on exploratory plans for a future DSM, including efforts to incorporate biomarkers into the next manual.

“I think in an ideal world, we sit together with the organizations that are running the manuals and have a discussion to see how we can move the current framework into one that we envision,” Kas said.

As reported by Medscape Medical News, the DSM subcommittee on biomarkers’ preliminary goals were first introduced publicly at this year’s APA meeting in June. A presentation there said the group’s mandate was to “bridge the gap between psychiatry and neuroscience” and to assess pros and potential cons of adding a biological approach to diagnostics.

The release of the next iteration of the DSM is about 4-5 years away, Maria Oquendo, MD, PhD, head of psychiatry at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and chair of the Future DSM Strategic Committee, said at the meeting.

If that goal were to be reached, with biological aspects incorporated into the manual, would that help the roadmap steering committee to reach more of their goals?

“That will be a very important milestone if we can have a placeholder for biology in the DSM, as well as making it a living document so that if new science emerges it can be considered and used,” Kas said.

Precision Pushback?

One concern on clinicians’ minds may be the expense of incorporating the measures into clinical practice, Williams noted.

“My sense is that the cost will be more upfront, as in the cost of the test. But then, for me, it’s about reducing subsequent costs that are currently being borne, such as during long waits for effective treatment,” she said.

She added that “the onus will be on us to make these measures accessible to everyone” to avoid socioeconomic disparities.

In the comment section of a recent Medscape Medical News story on precision psychiatry, some readers pushed back on the idea of psychiatry ever being part of precision medicine, asserting that the diagnostic process in psychiatry is more of an art than a science.

One respondent noted that other types of conditions have quantitative criteria, such as blood glucose and ECG Q waves. But for psychiatric disorders, “the brain is not readily accessible for testing.” Another commenter said outcomes are poor in conditions such as depression “not because of a lack of precision treatment but a lack of standardized treatment.”

“Is this neurobiology or psychiatry? Listening to the patient is the best clinical tool,” wrote another commenter.

“I think the pushback will shift when we show that we can get people better earlier and when the patients themselves request [these tools],” Williams said. “I think more doctors will adopt this when they see it in practice and when we have the operational steps in place.”

Another concern has been about the involvement of pharmaceutical companies in the framework’s planning stages. But one goal of the process is to achieve a very broad consensus among all stakeholders, Kas noted. That includes patients, clinicians, advocacy groups — and pharmaceutical companies.

“This is not just one voice from industry, but we do need their input. They’re a part of this chain to make it all work,” he said.

More Miles To Go

Current classification systems, including the DSM, include a common language and provide a foundation for prescribing guidelines and reimbursement, which enhances their utility, Kas and colleagues noted in their recent publication. However, they added, the biological validity of the current classifications is “poor.”

“We’re all extremely eager to begin to incorporate biological factors into our classification system” as more is learned, Jonathan E. Alpert, MD, PhD, chair of the Department of Psychiatry and Behavioral Sciences, Montefiore Einstein College of Medicine, Bronx, New York, told Medscape Medical News.

“This paper comes at a wonderful time because it dovetails with what the Future DSM committee is focusing on,” said Alpert, who also is the vice chair of the Future DSM Strategic Committee — but not part of the roadmap steering committee.

“I think both the ECNP and the APA recognize the critical importance of collaboration in what we’re doing, and we feel there’s mutual benefit to working together as much as possible,” he added.

Precision medicine is complementary to the attributes psychiatrists already bring to patient care and will “enrich psychiatry and not detract from the humanistic element that is such a core attribute,” Alpert said.

Kas noted that although publishing the roadmap was a milestone, “we have many more miles to go to make it all work. We need to learn, adjust, and move on.”

For clinicians, “I hope they embrace the idea and the concept, and that they will come to our meetings and join the discussions,” including about how all of this could be useful in their healthcare practice, he said.

“It’s a journey we need to do together,” Kas added.

Kas, Williams, and Alpert reported having no relevant financial relationships. Several of the journal authors reported serving as speakers or advisors for, serving on advisory boards of, receiving research support from, and/or being employees of various pharmaceutical companies. Full details are listed in the original article.