Esketamine is Safe and Effective for Treatment-Resistant Depression in a Real-World Outpatient Setting

Abstract: Approximately one third of major depression cases will not remit even with two or more medication trials, defined as treatment-resistant depression (TRD). The newest FDA-approved treatment for TRD in adults, esketamine, has a unique mechanism with comparatively rapid clinical effect. However, its long-term clinical effects and safety in a real-world outpatient setting are unstudied. Here we present a naturalistic sample of 158 patients with TRD in a community-based outpatient setting treated with esketamine, the largest longitudinal dataset of its kind. The cohort had a mean of 5 antidepressant trials and 3 prior augmentation trials, with prior history of suicide attempt, psychiatric hospitalization, TMS, and/or ECT treatment for 80% of patients. Treatment with esketamine nasal spray (8 or more treatments of 56 or 84mg) with maintenance treatment for a subset of patients analyzed out to 100 days, resulted in remission (absolute score 4), response (score reduction Short Description: Esketamine nasal spray can rapidly relieve even highly treatment-resistant depression (TRD). However, its long-term effects in the real world are unstudied. Here, for a large, community outpatient dataset, we report high remission rates for TRD of 11% and for anxiety of 19% (by PHQ-9, GAD-7, respectively), without safety or substance use disorder concerns. Critically, over 25% of patients who did not respond during the standard induction period did so with continued therapy.Name of Sponsoring Organization(s): Mindful Health Solutions