Study Finds Ketamine Telehealth Is A Safe And Effective Treatment For Anxiety And Depression
A study published in the Journal of Affective Disorders has concluded that at-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression.
Contents of this article
The Rise Of Ketamine Telehealth
Ketamine telehealth clinics (or online ketamine clinics) are on the rise. KetaMD was one such company that emerged from the pandemic, the first — in fact — to offer ketamine prescriptions over video calls. These clinics offer sublingual ketamine, so the drug comes in the form of tablets placed under the tongue and then left there to dissolve.
This new study acknowledges that at-home ketamine-assisted therapy, using remote monitoring through telehealth platforms, addresses barriers to access, including the COVID-19 pandemic.
This service is no doubt very convenient, as well as more affordable than in-person treatment. However, researchers wanted to look at whether this form of ketamine-assisted therapy was safe and effective in the treatment of anxiety and depression.
The Setup Of The Study
A large outpatient sample (1,247 patients) received ketamine-assisted therapy over four weeks through a telehealth provider (Mindbloom). The platform is accessible through an internet search or external physician/provider referral. Patients first had to complete an eligibility questionnaire and, if eligible, would then undergo a medical and psychiatric evaluation.
Patient records totaling 2,848 were reviewed with exclusion criteria in mind, which included certain health conditions, alcohol or drug addiction, and particular psychological risk factors (psychotic or manic symptoms and active suicidal ideation). Of these 2,848 people, 28 dropped out prior to the first ketamine session. 1,247 remained who could provide sufficient data for analysis.
Patients who met the eligibility criteria were sent a single 300-450 mg dose of sublingual, rapidly dissolving ketamine tablet to determine ongoing dosage. Ondansetron (a medication for nausea) and materials for the safe and proper administration of the ketamine (a digital blood pressure cuff, a journal, an eye mask, and instructions) were mailed as well.
To prepare for treatment, patients logged in to their web portal to review written and video materials. Each patient was also paired with a specially trained “guide” who was available for as-needed support by text message throughout treatment. Prior to the first medication session, patients met with their guide for a 30-minute video call to help establish a positive set and setting (or mindset and environment).
Guides also ensured the patient was using the blood pressure cuff properly and that blood pressure and heart rate were in a safe range. Patients were also required to abstain from food for three hours, fluids for one hour, and alcohol, stimulants, and benzodiazepines on the day of treatment.
During the medication session, patients held the ketamine tablet under their tongue or between the cheek and gums, without swallowing, for seven minutes, at which time they spit out all the saliva. Patients then lay down, put on their eye masks and headphones, and listened to the music provided.
After the sessions, the patients journaled and then had a video call with their guide. They later met with the prescribing clinician by video to describe their reaction. Integration sessions with the guide were held after the second session and then again after the fourth and final session. These were opportunities for patients to try to make sense of their experiences and apply them to their everyday lives.
The guides were not licensed professionals and did not provide psychotherapy, but they did offer active listening and warm and empathetic responses to the patients.
Researchers in the study analyzed mental health outcomes by using the 9-item Patient Health Questionnaire (which measures symptoms of major depression) and the 7-item Generalized Anxiety Disorder questionnaire.
The researchers also assessed side effects and adverse events through a self-report measure after the second and fourth sessions. Patients were asked “Have you noticed any issues with your physical or mental health since beginning treatment?” They had a number of response options to choose from.
Positive Results And A Small Number Of Adverse Events
The study found rapid, significant, and persisting improvements in symptoms for 62.8 percent of depressed patients and 62.9 percent of anxious patients. Moreover, after the last ketamine session, 32.6 percent of depressed patients achieved remission, while for anxiety patients the figure was 31.3 percent.
The researchers noted that these rates are “consistent with laboratory- and clinic-administered ketamine treatment.”
Side effects were reported by 59 (4.7 percent) patients after the second session and by 27 (3.8 percent) patients after the fourth. Four of these individuals discontinued treatment due to adverse events:
“one due to elevated heart rate, one due to worsening symptoms of depression, one needing to visit a urologist for follow-up on increased urinary pressure, including hematuria [the presence of blood in the urine] 24 hours after the fourth medication session, which resolved with confirmatory CT and ultrasound, and a final who presented to the ER for worsening anxiety and depression who was then admitted for ongoing psychiatric services.”
Nonetheless, with less than one percent of patients deteriorating, and a small number of people discontinuing the treatment due to adverse events, the authors conclude that “this form of ketamine treatment has an exceedingly desirable safety profile.”
There Are Still Safety Concerns
In an article for Psychology Today, Gail Serruya, M.D. — a psychiatrist who specializes in ketamine therapy — voiced her concerns about the potential dangers of ketamine telehealth services.
She points out that “there is very little long-term data on patients using low doses of ketamine over a substantial period of time.” This new study, like many others, didn’t evaluate this pattern of use. Yet in practice, this is how many patients will use ketamine telehealth services. We simply don’t know if taking ketamine regularly for long periods could open people up to harmful side effects.
This applies to any form of ketamine treatment, of course. Nonetheless, Serruya has said that ketamine telehealth services involve some unique challenges. What if difficult material arises during the ketamine journey, for instance? The patient may have a loved one acting as a sitter during the session, but this sitter might not be able to provide the same kind of support that a trained professional could.
Serruya highlights some other safety concerns:
“Although ketamine is known to be a very safe medicine, some telehealth companies are prescribing very high doses with little medical monitoring. What if someone’s blood pressure spikes to dangerous levels during the ketamine treatment? What if someone is lying down flat and vomits, and the sitter isn’t there? What if someone gets up to urinate, and the sitter isn’t there, and they fall? Caution and careful monitoring are essential to effective ketamine treatment.”
This latest research, based on the work of Mindbloom, helps to establish ketamine telehealth as a safe, convenient, and effective form of treatment. However, other clinics offering these services need to make sure the right appropriate planning and monitoring are in place, so that patient safety is always prioritized.