Original Research J Clin Psychiatry April 2020

Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2)

JCP 2020;81(3):10.4088/JCP.19m12891

Full Article Read the complete peer-reviewed article in J Clin Psychiatry. JCP 2020;81(3):10.4088/JCP.19m12891 Clinical Summary Patients with treatment-resistant depression often need sustained symptom control, but long-term ketamine-class treatment raises practical concerns about blood pressure, dissociation, cognition, urinary toxicity, sedation, and misuse. This study gives clinicians up to 1 year of safety and maintenance data for esketamine nasal spray plus an oral antidepressant in a large treatment-resistant depression cohort. FAQ What did SUSTAIN-2 find about the long-term safety of esketamine nasal spray in treatment-resistant depression? 10 questions
Key Takeaways Long-term exposure targets were achieved, with 364 patients dosed for 6 months and 136 for 12 months, giving clinicians a larger safety dataset than prior prolonged ketamine reports in treatment-resistant depression. 6 takeaways Clinical Guide How should clinicians adjust esketamine nasal spray dosing frequency over time in patients with treatment-resistant depression who respond to treatment? 8 steps Clinical Guide How should clinicians monitor and respond to the main safety risks during long-term esketamine nasal spray treatment for treatment-resistant depression? 9 steps