Amanda Miller was 30 years old and pregnant with her second child in Hershey, Pennsylvania, when she developed depression. After giving birth, her depression worsened. It is associated with a number of unknown health problems.
Miller, a neuroscientist, said she has seen many psychiatrists and received prescriptions for drug after drug. In two years, she tried four antidepressants and two antipsychotics. None of that helped—until her primary care doctor noticed high levels of an autoimmune marker in her blood.
A specialist then “ran every test in the book,” Miller said. Eventually, she was diagnosed with the autoimmune disease lupus and prescribed an anti-inflammatory steroid. Some of its symptoms leave within hours. Her depression soon subsided.
“I was convinced it was a placebo effect, but then it kept working,” Miller said.
Did inflammation contribute to her mental health problems? Miller thinks so, though he doesn’t know for sure. Her psychiatrists never raised the possibility, she said.
In many medical specialties, doctors can confirm whether to pursue a type of treatment through tests, such as blood work, imaging, and biopsies. However, mental illness has historically been diagnosed and treated based on outward symptoms. This may change.
In a January article, the American Psychiatric Association included ideas for how it might incorporate biomarkers — biological indicators of mental illness that can show up on diagnostic tests — into its future editions. Diagnostic and Statistical Manual of Mental Disorders.
of the DSMsometimes called the “psychological bible” because of its influence in the field, provides criteria for diagnosis. It is used by clinicians who evaluate patients and by insurance companies to decide whether to cover care.
‘Coherent’ research is needed
Biomarkers of mental illness are not yet ready for widespread use, the paper stressed. Scientists have studied this topic for decades, with little to show for it. The APA paper said these metrics are reliable and valid enough to justify their use in patient care, and other researchers have raised questions about how their use could affect health care costs, insurance coverage, and patient privacy.
Adding biomarkers DSM Jonathan Alpert, author of the January paper and vice chair of the APA’s Future DSM Strategy Committee, said it would be “a big deal.”
Access to test results, along with symptoms, can streamline insurance coverage decisions and help clinicians make quick and accurate diagnoses and treatment recommendations. If a patient’s biology suggests that they will respond better to one treatment than another, their doctor can’t waste time starting there.
Currently, prescribing psychiatric medications can be “a bit of a crapshoot,” with clinicians unable to predict whether they will work for a particular patient, said Matthew Eisenberg, director of the Center for Mental Health and Addiction Policy at Johns Hopkins University’s Bloomberg School of Public Health.
In one seminal study, funded by the National Institute of Mental Health in the early 2000s, about 30% of study participants with depression found their symptoms disappeared with their first antidepressant treatment. The study is still one of the most robust antidepressant trials ever conducted – although researchers have recently argued that fewer people treated by the drug suggest its results.
Such a trial-and-error approach can lead to ineffective and unnecessary prescriptions, a subject of attack by proponents of the American Health Reform led by US Health and Human Services Secretary Robert F. Kennedy, Jr. Kennedy specifically criticized antidepressants, linking them to violence without evidence and after a mass shooting by doctors for prescribing drugs for children.
HHS is analyzing psychiatric diagnosis and prescribing trends and evaluating alternative approaches to mental health treatment, with a particular focus on children, spokeswoman Emily Hillard said in a statement. Hilliard did not respond to a question about Kennedy’s past comments.
Biomarkers have already been used to guide treatment in other medical disciplines, such as oncology. Arizona, Georgia, Kentucky, Texas, and more than a dozen other states require insurers to cover such tests. Blood and imaging tests are now also used in the diagnosis of Alzheimer’s disease.
The APA included in its article various ways that psychiatric biomarkers could be used in the future – such as examining brain function, genetic profiles, or immune markers that are associated with certain psychiatric conditions, including schizophrenia and substance use disorders.
In depression, for example, about a quarter of patients have high levels of an inflammatory protein, called C-reactive protein, which can be detected through a blood test. Research has shown that people with high levels of this protein respond better when drugs alter dopamine levels in the brain, rather than just using selective serotonin reuptake inhibitors, or SSRIs, a common type of antidepressant. According to the APA paper, C-reactive protein still needs “robust validation” as a biomarker, but it is among the most promising currently under investigation.
Achieving such accreditation would require a “coordinated, well-funded” research effort, the APA wrote — a tenuous prospect since the Trump administration has slashed funding for research.
The National Institute of Mental Health alone had at least 128 grants, worth nearly $173 million, canceled by 2025, according to a research letter in the journal JAMA.. Although some grants have been returned, researchers who rely on federal money still fear their work is vulnerable to cuts.
“Continued and proactive funding of mental health-related research is desperately needed,” Alpert said, but scientists must contend with the “uncertainty of the funding landscape.”
Impact of Ripple on coverage, costs
Health care costs are higher among patients with poorly controlled mental illness, due to costs such as hospital visits, outpatient appointments, and prescriptions. Some studies suggest that biomarker testing can save money by speeding up the right treatment and avoiding these costs.
A modeling study estimated that tests to find genetic components that can influence drug effects could save the Canadian health system $956 million over 20 years if used among adults with major depression in British Columbia. Another study, by Spanish researchers, found that such tests reduced costs for the majority of 188 participants with severe mental illness.
Whether this will be true in the US health care system is unknown. In the short term, Johns Hopkins Eisenberg said, an approach that uses biomarkers could increase health care costs due to testing costs.
Insurers may refuse to cover expensive biomarker tests, he added. “It takes a while for new science to be proven safe and effective,” Eisenberg said. “And once it is, insurance companies don’t cover it right away.”
Some researchers have raised concerns that insurers or employers may discriminate against people whose biological profiles suggest they are at risk of developing serious neuropsychiatric conditions.
It’s an “important moment” to consider legislative approaches to protect patients and train doctors on how to properly use these tools, said Gabriel Lazaro Muse, a member of Harvard Medical School’s Bioethics Center.
“I don’t think the field of psychiatry is ready to handle that right now,” he said.
The mental health system is not ready to “jump in with both feet,” said Andrew Miller, a professor of psychiatry and behavioral sciences at Emory University School of Medicine, who studies inflammation-related depression. But the APA’s embrace of biomarkers marks the “beginning of a revolution.”
“It’s a recognition … what we’ve done so far is not enough,” Miller said. “And we can do better.”
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