• At-home ketamine therapy is a safe and effective way to alleviate symptoms associated with anxiety and depression, according to results from the largest-ever clinical study on ketamine therapy to date.
  • At-home therapy using ketamine tablets that dissolve under the tongue could make ketamine therapy more accessible than when administered intravenously or intramuscularly in clinical settings.
  • While some people may experience relief from anxiety or depression with ketamine therapy, experts caution that more research is still needed to better understand how it compares to traditional treatments.

Several sessions of at-home ketamine therapy supported by telehealth are a safe and effective way to treat moderate to severe anxiety and depression, a new study found.

The results, recently published in the Journal of Affective Disorders, suggest that an at-home approach using ketamine tablets that dissolve under the tongue rather than intravenous (IV) infusion or intramuscular injection could make ketamine therapy more accessible.

But experts caution that more rigorous studies are still needed to determine how well ketamine therapy compares to traditional treatments for anxiety and depression.

Ketamine, once mainly used as an anesthetic, is gaining ground as a potential treatment for depressive disorders and suicidal ideation in clinical settings.

Medical professionals may administer ketamine directly into a vein (intravenous or IV) or into a muscle (intramuscular injection) in clinical settings.

The Food and Drug Administration (FDA) has also recently approved esketamine, a form of ketamine that’s administered with a nasal spray. Esketamine therapy may be used in conjunction with an oral antidepressant for the treatment of depression in people who didn’t benefit from antidepressants alone.

In addition, ketamine tablets may also be dissolved under the tongue (sublingual), which has been shown to improve symptoms in people with treatment-resistant depression. (Sublingual ketamine therapy was used in the new study).

In the current study, which was the largest clinical study of its kind to date, over 1,200 adults received at-home sublingual ketamine therapy through Mindbloom, a telehealth platform that offers this therapy in 30 U.S. states.

All participants included in the study were diagnosed with severe anxiety, moderate to severe depression, or both.

Prior to their first medication session, participants met with a psychiatrist through a video call. The clinician evaluated people to see if ketamine therapy would be a good fit for them.

“Although at-home sublingual ketamine therapy can be an effective, safe treatment option for people experiencing anxiety or depression, it is not for everyone,” said study author Dr. Leonardo Vando, Mindbloom’s medical director. “That’s why Mindbloom’s clinicians play a critical role in determining whether treatment is appropriate for each prospective client.”

Throughout the study, participants met with a behavioral coach who helped participants prepare for their first session and provided support between sessions, including by text message.

The at-home therapy protocol included four weekly medication sessions. During each session, participants dissolved the ketamine tablet under their tongue, put on an eye mask, and listened to music for an hour. Afterward, they wrote in a journal about the experience, which helped them reflect on and integrate their feelings and insights.

As a precaution, study participants were also given a digital blood pressure cuff so they could monitor their blood pressure after taking the medication since ketamine can increase blood pressure.

After four medication sessions, almost 89% of people saw improvements in their anxiety or depression symptoms, either immediately or after the first two sessions.

Overall, almost 63% of people had a 50% or greater reduction in their anxiety or depression symptoms. In addition, researchers saw a decrease in the number of participants who reported having suicidal thoughts or ideas.

Side effects of the ketamine treatment were rare, reported by fewer than 5% of participants. Only four people dropped out of the treatment due to adverse events.

“This study demonstrated that at-home treatments can be incredibly effective with a low rate of side effects, especially when compared against studies for SSRIs [selective serotonin reuptake inhibitors],” Vando said. (SSRIs are commonly prescribed antidepressants and include Celexa, Prozac and Zoloft.)

Subhdeep Virk, MBBS, clinical associate professor of psychiatry and behavioral health at The Ohio State University Wexner Medical Center in Columbus, who was not involved in the new study, said one of the strengths of the research was the large number of participants.

Still, she noted the study is just a “starting point” and called for more research, in particular a randomized placebo-controlled clinical trial (RCT). This type of study would allow researchers to compare the safety and effectiveness of at-home ketamine therapy to standard treatments for anxiety, depression, or both. In the new study, there was no control (or comparison) group.

Virk added that following patients longer — from 1 to 6 months after the end of treatment — would also provide information on the long-term benefits of at-home ketamine therapy. “We do have a lot of data on ketamine,” she said. “We already know that it helps much more quickly than some of the other antidepressants. What we don’t know about this treatment is how sustained those effects are.”

In her clinic, Virk said she provides both IV infusion and intranasal ketamine therapy to patients, so she’s familiar with its potential as a treatment for anxiety and depression. However, because this is a newer treatment, she tells patients she’s “cautiously optimistic” about ketamine’s role as a treatment.

“We definitely see results — if you compare ketamine to traditional antidepressants, the response is quicker,” she said. “But it is not a miracle treatment. It has its limitations, and we still need to be careful in selecting patients when we are providing these treatment options.”

Throughout the pandemic, telehealth increased access to many different types of medical care. Some researchers hope that internet-based healthcare offerings will continue going forward, and help ensure more equitable access to care.

Dr. David A. Merrill, an adult and geriatric psychiatrist, and director of the Pacific Neuroscience Institute’s Pacific Brain Health Center, said the new study showed not only the value of sublingual ketamine therapy but also how to successfully incorporate telehealth into a treatment program.

“This was a good demonstration of the added value of telehealth that we’ve gained through the pandemic experience where we needed to have options to treat people remotely,” Merrill said.

The positive results of the study suggest the at-home approach to ketamine treatment could increase access to this therapy for people with anxiety and depression.

Merrill agreed the results seem promising. He added that at-home ketamine therapy could potentially provide a safe and effective option in areas where effective treatment options are limited, and where access to care is increasingly difficult.

“If the costs can be afforded, this is another potential avenue for patients to get treatment for disabling anxiety and depression,” Merrill said.

According to the study authors, sublingual ketamine costs $200 to $250 per treatment dose, which is cheaper than ketamine IV infusion.

However, they also noted that few health plans cover the cost of ketamine treatment for depression and anxiety. This means patients would have to pay out of pocket, which could limit the reach of this therapy.

According to Merrill, that’s another reason why more rigorous clinical trials are needed.

“My hope is that these preliminary findings are used to design [RCTs] and gather the evidence needed to convince insurance payers to cover not only telehealth in the long term, but also to cover things like ketamine-assisted psychotherapy, whether they’re in the home or in the office,” he said.

As more research shows the potential for different ketamine therapies as a treatment for mental health conditions like anxiety and depression, medical experts agree that more rigorous studies are still needed to determine ketamine’s long-term effectiveness.

If at-home sublingual ketamine therapy continues to be effective, it could pave the way for a more cost-effective approach to using ketamine for therapeutic purposes.

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