TY - JOUR
T1 - At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression
T2 - Findings from a large, prospective, open-label effectiveness trial
AU - Hull, Thomas D.
AU - Malgaroli, Matteo
AU - Gazzaley, Adam
AU - Akiki, Teddy J.
AU - Madan, Alok
AU - Vando, Leonardo
AU - Arden, Kristin
AU - Swain, Jack
AU - Klotz, Madeline
AU - Paleos, Casey
N1 - Funding Information:
None. Modest financial support for AM, TDH, CP, and TJA, as well as providing the data. Data can be made available upon reasonable request to the corresponding author, with a statistical analysis plan, and a fully executed data use agreement.
Publisher Copyright:
© 2022 The Authors
PY - 2022/10/1
Y1 - 2022/10/1
N2 - Background: At-home Ketamine-assisted therapy (KAT) with psychosocial support and remote monitoring through telehealth platforms addresses access barriers, including the COVID-19 pandemic. Large-scale evaluation of this approach is needed for questions regarding safety and effectiveness for depression and anxiety. Methods: In this prospective study, a large outpatient sample received KAT over four weeks through a telehealth provider. Symptoms were assessed using the Patient Health Questionnaire (PHQ-9) for depression, and the Generalized Anxiety Disorder scale (GAD-7) for anxiety. Demographics, adverse events, and patient-reported dissociation were also analyzed. Symptom trajectories were identified using Growth Mixture Modeling, along with outcome predictors. Results: 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.
AB - Background: At-home Ketamine-assisted therapy (KAT) with psychosocial support and remote monitoring through telehealth platforms addresses access barriers, including the COVID-19 pandemic. Large-scale evaluation of this approach is needed for questions regarding safety and effectiveness for depression and anxiety. Methods: In this prospective study, a large outpatient sample received KAT over four weeks through a telehealth provider. Symptoms were assessed using the Patient Health Questionnaire (PHQ-9) for depression, and the Generalized Anxiety Disorder scale (GAD-7) for anxiety. Demographics, adverse events, and patient-reported dissociation were also analyzed. Symptom trajectories were identified using Growth Mixture Modeling, along with outcome predictors. Results: 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.
KW - Anxiety
KW - Digital health
KW - Ketamine-assisted therapy
KW - Major depression
KW - Psychedelic-assisted therapy
KW - Real-world
KW - Telemedicine
KW - Pandemics
KW - Prospective Studies
KW - Humans
KW - COVID-19
KW - Ketamine/adverse effects
KW - Anxiety/psychology
KW - Depression/psychology
UR - http://www.scopus.com/inward/record.url?scp=85133859272&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85133859272&partnerID=8YFLogxK
U2 - 10.1016/j.jad.2022.07.004
DO - 10.1016/j.jad.2022.07.004
M3 - Article
C2 - 35809678
AN - SCOPUS:85133859272
SN - 0165-0327
VL - 314
SP - 59
EP - 67
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
ER -