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Examining the benefits and the risks of ketamine therapy

Inside Initia Nova medical center in Wilmington where patients undergo ketamine therapy treatments.
Rachel Sawicki
Delaware Public Media
Inside Initia Nova medical center in Wilmington where patients undergo ketamine therapy treatments.

The sedative drug ketamine was approved by the FDA as an anesthetic in the 1970s, but more recently it’s seeing some use to treat severe depression and various mood disorders.

Some call it life-changing, but concerns over scant oversight and abuse remain following a pandemic that saw telehealth and looser regulations allow a black market to flourish.

Delaware Public Media’s Rachel Sawicki reports on what patients, doctors, and experts are saying about ketamine’s antidepressant properties and the potential dangers.

“I had never been able to see the world through a lens of peace, or a lens of calm. From my earliest memories, I was being tortured or touched by my dad, and then high school wasn't good for me, I got in fights all the time, and then I went to war.”

Wayne Packard joined the military in 2007 to become an Explosive Ordnance Disposal technician. He told everyone he joined because a family friend inspired him.

“The truth really is, at that time I was just not in a good place mentally, so I was looking for an easy way out instead of killing myself,” Packard says. “I figured why not join the military, they’ll probably do it for me, and I’ll just die a hero.”

Packard served for 12 years, a period marked by alcoholism, strained relationships with family and friends and worsening depression. After he left in 2019, the VA gave him a 70% disability rating – later amended to 90% – and his wife told him to see a therapist.

Packard’s troubles began in his early childhood, including being sexually molested by his father. He says in therapy, he talks more about his childhood trauma than his deployments.

Packard says he’s found help through ketamine treatments.

“At 35 or 36 years old, under the influence of a psychedelic, was the first time I ever felt safe,” he says. “And having that ability to look at the world now through that lens, or perspective, has totally changed me."

Packard goes to Initia Nova in Wilmington for Ketamine-assisted psychotherapy. It combines low doses of ketamine with talk therapy to treat depression, anxiety, and other disorders. The team is made up of a doctor who administers the ketamine, a nurse practitioner that monitors his vitals, and a therapist who talks to Packard while the drug does its work.

John Doughtery is the facility's medical director.

“I’ve done several thousand infusions at this point and seeing people who are acutely suicidal when they come in, and they’re no longer suicidal when they leave an hour or hour and a half later, I mean it’s just mindblowing to me,” Doughtery says. “Seeing these people who have been horrifically depressed for months, years, entire lifetimes, all of a sudden they’re asking the question, not ‘am I going to feel better?’ but ‘oh my god what am I going to do with my life now?’”

“At 35 or 36 years old, under the influence of a psychedelic, was the first time I ever felt safe. And having that ability to look at the world now through that lens, or perspective, has totally changed me."
Wayne Packard, military veteran

During his first treatment, Packard says he imagined himself as a giant piece of pink and white taffy floating in space. He could extend himself to every piece of the universe, fold, twist, roll and stretch, but never broke.

“It’s malleable it’s going to pull, it’s going to twist, but it’s not going to tear, it isn’t going to break,” Packard says. “So it’s a resilient thing, and that represents me being resilient.”

He says that realization saved his life.

Doughtery says the important part of the treatment is the experience – giving patients an opportunity to disconnect from reality.

Through telemedicine, at-home therapy has also emerged as a popular treatment option.

Dylan Beynon is CEO of Mindbloom, the largest at-home provider of ketamine.

He started Mindbloom after losing his mother and sister to depression and addiction – despite using traditional treatments like therapy, SSRI’s and rehab – and believes the antidepressant properties seen from lower doses of ketamine can make a difference.

“People often have insights into changes they want to make or challenges or issues that are holding them back from achieving the mental health goals that they have been seeking for a long time,” Beynon says.

In October last year, Mindbloom’s Medical Director Leonardo Vando co-authored the largest clinical study to-date on at-home ketamine therapy. Roughly 1250 people with depression and anxiety completed four rounds of treatment, and nearly 89% of people saw improvements in their symptoms either immediately or after the first two sessions. And 63% of people also reported a 50% or greater reduction in their symptom severity.

“This is by far the most robust effect of any treatment available right now for suicidal ideation,” Vando says. “And over 30% remission rates, meaning no symptoms whatsoever, this is unheard of. And fewer than 5% of people had side effects, and side effects were relatively mild, nausea, headache, etcetera.”

Beynon argues ketamine should be a frontline treatment rather than a last resort based on the results these studies have produced so far, and he’d like to make treatment affordable for everyday people.

But some caution there is still more to learn first.

Dr. Gerard Sanacora is a Psychiatry Professor and Director of the Depression Research Program at Yale University.

He was the leader of the team that pioneered the discovery of ketamine as a treatment for depression. He says in the late 1980s to early 1990s, there was increasing evidence to suggest other brain areas were likely to play a major role in depression, especially neurotransmitter systems that control neuroplasticity within the brain.

“Ketamine initially has its effects at a very specific receptor, the NMDA glutamate receptor, but it then initiates a cascade of events that we believe induces what we call neuroplasticity,” Sanacora says. “So it’s changes in the brains ability to communicate with each other, actually forming new synapses, and strengthening synapses, that allows the brain to communicate more efficiently with itself. And the idea is that would make the brain more adaptable and help to change some of the circuitry that has been so hard-wired into these people suffering from depression that they may be able to change their cognitive and emotional patterns.”

Sanacora emphasizes that ketamine is not FDA approved, but a strain of it is, called esketamine, which is typically administered through a nasal spray, and the FDA has only approved it to treat major depressive disorder.

 Inside the Initia Nova medical center in Wilmington
Rachel Sawicki
Delaware Public Media
Inside the Initia Nova medical center in Wilmington.

Both Mindbloom and Initia Nova operate outside of FDA approval, but there are studies that point to better outcomes than the esketamine nasal spray that is approved.

But Sanacora says when ketamine is used to treat other mental disorders outside of depression, the research thins out.

“It doesn’t mean that it’s not effective there,” he says. “For PTSD there’s mixed studies, there’s some showing good effects theres some showing not so good effects, the same for OCD, the same for other disorders, but none of them really meet that high-quality, rigorous demand that would be required by the FDA to grant approval.”

Sanacora adds ketamine is unlike opiates, which have an immediate physical addiction, but there is still risk for misuse.

“We really just don’t know how safe it is to be giving this,” Sanacora says. “There are real risks, real concerns with the idea that this would be taken by patients at home, both for the patient themselves, and for society in general, with the risk of drug diversion. So it’s a difficult thing. You’re balancing patient access and safety, which is always a concern.”

Doughtery points to at-home therapy as one of those risks.

And he says the esketamine nasal spray - spravado - doesn’t always give accurate dosing, but the IV treatment is more controlled.

“If you’re really anxious, I can slow it down, or if you’re feeling like you might have a panic attack, we can stop it and counsel you and help you work through it,” Doughtery says. “If you’re feeling nauseous I can give you nausea medicine through the IV. But with the IM or the nasal spray or some of these other things like the oral versions, once you take those things, you can’t take it back. We can’t stop things or slow it down or alter experiences, and I think for ketamine assisted work, especially for therapy and for trauma, it’s just so nice to have those abilities to be able to manipulate the variables, it makes people feel a lot more comfortable.”

Like any medicine, everyone responds to ketamine treatment differently, but Doughtery says on average, around 70% of his patients see improvement in their symptoms.

"I tend to see people in the field and people in the media at times too try to simplify it into black and white and it’s just not so simple here."
Dr. Gerard Sanacora, Psychiatry Professor and Director of the Depression Research Program at Yale University

Sanacora is still studying ketamine. He’s now looking at how it can treat mood disorders associated with Parkinson's disease. But any study that would lead to FDA approval will take thousands of people and hundreds of millions of dollars.

“I tend to see people in the field and people in the media at times too try to simplify it into black and white and it’s just not so simple here,” Sanacora says. “It’s not one is good, one is right one is wrong, it really is a difficult decision for people to make.”

Doughtery agrees, noting that in addition to a lack of sizable and comprehensive studies, they don’t know if there are any long-term side effects - something patients need to consider.

“When it comes to depression and PTSD and some of these things, when you’re talking about quality of life and people can’t function, and I’m saying there’s something here that can greatly improve your life, even if there’s a tiny risk of something 30 years from now that we can’t predict, most people are going to say, “I want to sign up for that thing, because I’m not living,’” Doughtery says.

Doughtery adds there are other downsides. The cost isn’t covered by insurance, and there is a substantial time committment.

But for some the decision is easy. Wayne Packard has returned for two treatments since his initial 3-week series. He says his life has changed forever.

“To say night and day isn’t enough,” Packard says.

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Rachel Sawicki was born and raised in Camden, Delaware and attended the Caesar Rodney School District. They graduated from the University of Delaware in 2021 with a double degree in Communications and English and as a leader in the Student Television Network, WVUD and The Review.