State health department changes research policies at Spring Grove psych hospital

In November 2008 — a little more than a year after William Garrett’s doctors diagnosed him with schizophrenia — he started shouting in the back seat of his mother’s car while she drove them to a museum. Then, he punched her in the head.

Garrett had started experiencing distressing delusions during his freshman year at Johns Hopkins University. He’d come to his mother, Kristan Kanyuch, holding his head and crying because he thought his neighbors were using telepathic powers to give him a stroke.

He was able to get treatment through an inpatient study at the National Institute of Mental Health — where his mom picked him up to take him to the museum — but he was scheduled to be discharged soon. And it seemed like Kanyuch had suddenly become a trigger for the paranoia caused by his illness.

Kanyuch was panicked. She didn’t have the money to send him to a private hospital, since she had quit her job to take care of him. He couldn’t come home to Harford County, where he could be a danger to Kanyuch and his little sister. She feared homelessness was his only option.

Instead, she was able to get her son a bed in the Treatment Research Unit at Spring Grove Hospital Center — a state psychiatric hospital in Catonsville, where Garrett started taking clozapine, an under-prescribed drug used to treat people with treatment-resistant schizophrenia. Fifteen years later, Garrett is still on clozapine, something he credits, along with the unit, with saving his life.

But the unit’s future is uncertain. The Maryland Department of Health plans to terminate the agreement that created it, health department spokesman David McCallister said Friday in an email.

The health department opened the unit in 1989 with the help of the University of Maryland, Baltimore. Officials involved in its creation had two main goals: providing “state-of-the-art” clinical care to people with treatment-resistant schizophrenia, a population that constitutes about a third of those with the illness, and researching treatments to help them manage their symptoms.

That 35-year-old arrangement is now outdated, McCallister wrote, though he added that its termination would not affect patients or employees at Spring Grove. The unit will continue providing clinical care to patients, though it will no longer be a specialized research unit.

The state’s decision follows months of tumult at the Maryland Psychiatric Research Center — a program under the University of Maryland School of Medicine that oversees research on the Treatment Research Unit. In March, the health department told the center to temporarily stop enrolling inpatients in studies while it reviewed the center’s research protocol.

While health department spokesman Chase Cook said the pause allowed officials to determine “future steps” for enrolling patients who arrived at the hospital through a court order, some mental health advocates were confused by it. They expressed concern in interviews with The Baltimore Sun and in letters to the health department that it would restrict care options for patients and deny them autonomy to make informed decisions about treatment.

“It is imperative that we continue to advocate for the rights of patients to access innovative treatments and participate in research studies that have the potential to transform lives,” Dr. Theodora Balis, president of the Maryland Psychiatric Society, wrote in a May letter to the health secretary, Dr. Laura Herrera Scott. “Patients have the right to choose their course of treatment. The denial of the choice to participate in a research study denies them this choice.”

In an email, Deanna Kelly, the research center’s acting director and director of its treatment research program, said that to her knowledge, there’s never been a complaint from patients, families or physicians about the unit in the three decades it has existed.

For the last three months, Kelly said, only the 17 patients enrolled in the two inpatient studies the center was running before the pause began could participate in such research.

One study funded through the UMB Foundation examined the benefits schizophrenia patients may experience from eating a ketogenic diet. That’s a high-fat, low-carb plan that some evidence shows may help with the symptoms of severe mental health conditions. The other is a multisite study — funded by the National Institute of Mental Health — that looks at the efficacy of clozapine in reducing violent and aggressive behavior in people with schizophrenia.

Kelly received a letter Tuesday from the Spring Grove Research Committee, saying she could resume enrolling patients in the clozapine study, but not the keto diet study.

That’s because the health department is moving forward only with federally funded studies at department-run institutions, McCallister said. The new rule only affects studies with direct patient contact, he said.

Deborah Kotz, a spokeswoman for the University of Maryland School of Medicine, said the university learned June 21 of the new policy. During the pause on enrollment, Kotz said, the university cooperated with state officials, providing them with information on the research protocol, federal regulations and ethical conduct of the research, which is overseen by the university’s Accredited Human Research Protections Program.

“UMB researchers continue to uphold the highest standards of research procedures to advance science, and we remain hopeful that future negotiations and collaborations will allow us to revisit opportunities for research supported by funding beyond the federal government,” she said.

The letter Kelly received from the hospital research committee told her she could continue the keto study until July 24. However, the patients enrolled have finished participating, she said.

She worries the new policy could hinder future research on schizophrenia in Maryland. Between 2017 and 2022, the National Institute of Mental Health funded only one drug trial for the illness, despite it affecting about 3.8 million Americans and having an economic burden of $343 billion in 2019, according to a 2023 analysis of the institute’s research portfolio . The federal agency also funded 100 fewer research grants for schizophrenia in 2021, compared with 2016, according to the analysis.

Protecting participants

The patient population at Spring Grove today looks different from the one Garrett joined about 15 years ago when he was admitted. Most of the patients at the psychiatric hospital of nearly 400 beds are charged with a crime, but determined by a judge to be “incompetent to stand trial.” That means they didn’t have the mental capacity to participate in legal proceedings at the time of the judge’s ruling.

Unlike patients at the maximum-security forensic psychiatric Clifton T. Perkins Hospital in Jessup, Spring Grove patients are typically charged with minor offenses, such as trespassing, loitering and theft under $100, Kelly said. They’re a vulnerable group of people, who often have a history of homelessness and untreated or treatment-resistant mental illnesses. Roughly 70% are Black. Many are from economically disadvantaged families or have fallen from higher socioeconomic levels due to illness or drug use.

Someone can be incompetent to stand trial and be able to make medical decisions, Kelly said. Figuring out whether a patient has the capacity to consent to participate in the center’s research includes a thorough evaluation, conducted by a researcher and observed by at least one other staff member. The patient is asked to explain a study’s procedures and risks, how they can end their participation, and how to report any discomfort or adverse side effects, as well as other questions.

It’s a misconception that people with schizophrenia can’t make good decisions for themselves, said Dr. Fred Jaskog, research director at the North Carolina Psychiatric Research Center, a program under the University of North Carolina School of Medicine. The center is also participating in the clozapine study.

“You can hear voices, you can have auditory hallucinations, you can be paranoid,” he said, “and you can still step back and say, ‘I understand these symptoms are the way they are and they’re part of my illness. But I also understand that here is this treatment that you’re recommending, and it has these side effects and it can have these potential benefits.’”

Since court-ordered patients at Spring Grove are considered “prisoners” under federal research laws, they have more protections than most study participants, Kelly said. For instance, all inpatient studies must have the potential to provide direct benefits to the patients. Patients also must undergo a lengthy informed consent process, designed to ensure they’re not being coerced. And if a judge has determined that a patient can’t make medical decisions, they’re ineligible.

Researchers don’t recruit patients for studies, Kelly said. They’re considered for participation only if they get referred by one of their doctors or they volunteer.

Additionally, several committees — including the hospital research committee and multiple institutional review boards — keep close tabs on the research. Dr. Charles Richardson, who was the Treatment Research Unit’s director from 1994 until his retirement in 2021, chairs the data safety monitoring board charged with periodically reviewing data collected by center researchers for patient safety. Inpatient studies run by the center are incredibly low-risk, he said. It’s rare for them to report any serious side effects experienced by participants.

“It’s not as if they’re cowboys without oversight,” he said.