Thomas D. Hull, Matteo Malgaroli, Adam Gazzaley, Teddy J. Akiki, Alok Madan, Leonardo Vando, Kristin Arden, Jack Swain, Madeline Klotz, Casey Paleos, 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, Journal of Affective Disorders, Volume 314, 2022, Pages 59-67, SSN 0165-0327.
Highlights:
· Large, real-world data for an approach to delivering at-home ketamine-assisted therapy to ensure safety and increase access
· Influence of side effects and degree of dissociation for this treatment were determined for subpopulations
· Novel use of unsupervised machine learning to more fully characterize patient response profiles
· Strong results for both depression and anxiety for a large and geographically diverse patient population
Result:
A sample of 1247 completed treatment with sufficient data, 62.8 % reported a 50 % or greater improvement on the PHQ-9, d = 1.61, and 62.9 % on the GAD-7, d = 1.56. Remission rates were 32.6 % for PHQ-9 and 31.3 % for GAD-7, with 0.9 % deteriorating on the PHQ-9, and 0.6 % on the GAD-7. Four patients left treatment early due to side effects or clinician disqualification, and two more due to adverse events. Three patient subpopulations emerged, characterized by Improvement (79.3 %), Chronic (11.4 %), and Delayed Improvement (9.3 %) for PHQ-9 and GAD-7. Endorsing side effects at Session 2 was associated with delayed symptom improvement, and Chronic patients were more likely than the other two groups to report dissociation at Session 4.
Conclusion:
At-home KAT response and remission rates indicated rapid and significant antidepressant and anxiolytic effects. Rates were consistent with laboratory- and clinic-administered ketamine treatment. Patient screening and remote monitoring maintained low levels of adverse events. Future research should assess durability of effects.
