At home, sublingual ketamine-assisted therapy (KAT) is safe and effective for patients with moderate to severe anxiety and depression, according to study findings published in the Journal of Affective Disorders.
In this prospective study, licensed clinicians provided patients with 4 weeks of KAT through an online platform available to patients in 15 states. In this study, both clinicians and guides (people with behavioral coaching experience and related certifications), were involved with patient education and monitoring medication administration.
Symptoms were collected and assessed using the Patient Health Questionnaire (PHQ-9) for depression and the Generalized Anxiety Disorder scale (GAD-7) for anxiety.
Participants (N=1247) needed access to the internet, a diagnosis of depression or anxiety based on a video interview, and a score of 10 or higher on the PHQ-9 or GAD-7 at baseline to be considered for the study. The mean age of participants was 40±9 years and 5% of patients lived in zip codes assigned to rural areas.
Patients were given single doses of a sublingual, rapidly dissolving ketamine tablet. To prepare for treatment, participants reviewed educational materials provided by the clinicians and were assigned to a guide for as-needed support via text. Guides met with the patients directly before the administration of ketamine to review educational material and to confirm that the patient had a peer monitor physically present with them to proceed.
Patients met with the prescribing clinician 1 to 2 days after medication administration to assess the treatment. For the remaining doses, patients met with their guides and could request to speak with their prescribing clinicians. Symptoms were monitored daily by guides and patients were instructed to complete weekly symptom surveys. Patient assessments were conducted at baseline, at 2 weeks, and at 4 weeks.
Overall, 62.8% (effect size [d], 1.61) of participants reported a 50% or greater improvement on the PHQ-9 compared with 62.9% (d, 1.56) of participants on the GAD-7. Upon analysis of symptom trajectories, 3 patient classes emerged: improvement (79.3%), chronic (11.4%), and delayed improvement (9.3%).
The improvement group was characterized by patients with lower PHQ-9 and GAD-7 scores at baseline whose scores were steadily decreasing throughout the study. The chronic group was characterized by higher PHQ-9 and GAD-7 scores at baseline and maintained these scores throughout the study. The delayed improvement group began with elevated PHQ-9 and GAD-7 scores and showed dramatic improvement in the final weeks of treatment.
Results indicated that individuals in the delayed improvement group (odds ratio [OR], 4.42; 95% CI, 2.02-9.67; P <.001) were more likely to report side effects at session 2 compared with the chronic group (OR, 1.26; 95% CI, 0.55–2.86; P =.582).
Remission rates were approximately 32% for both PHQ-9 and GAD-7 with a deterioration of less than 1% in patients.
Regarding limitations, this trial was relatively short and there was no follow up, making it difficult to assess-long term efficacy of this treatment.
“The combination of strong and rapid effects with very small numbers of adverse events suggest that at-home sublingual ketamine therapy is an important avenue for overcoming long-standing barriers to depression and anxiety treatment, safely and conveniently. Evaluating the durability of these effects will be important for future research,” the study authors noted.
Hull TD, Malgaroli M, Gazzely A, et. al. At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial. J Affect Disord. Published online July 6, 2022. doi:10.1016/j.jad.2022.07.004