Investigators noted sustained improvement in depressive symptoms for up to 6.5 years.
Results from a recent study showed that flexibly dosed esketamine nasal spray demonstrated sustained improvements in depressive symptoms in adults with treatment-resistant depression (TRD) for up to 6.5 years. The study investigators shared these results in a poster presentation at Psych Congress 2023.
The poster presentation, titled “Long-Term Efficacy of Esketamine Nasal Spray Dosed in Accordance With US Prescribing Information in Adults With Treatment-Resistant Depression: A Subgroup Analysis of the SUSTAIN-3 Study Up to 6.5 Years,” described some of the results from the SUSTAIN-3 clinical trial titled “A Long-Term Safety Study of Esketamine Nasal Spray in Treatment-Resistant Depression (SUSTAIN-3),” a phase 3, open-label, long-term extension study.1,2
The purpose of the SUSTAIN-3 study is to assess the overall tolerability and safety of esketamine nasal spray in individuals with TRD over the course of 2 phases: a 4-week induction phase and a variable-duration optimization and maintenance phase.1,2
For the subgroup analysis discussed in this poster presentation, the investigators focused specifically on the long-term efficacy of esketamine nasal spray in adults with TRD who were dosed according to US prescribing information, drawing efficacy data from the SUSTAIN-3 study. To explore this, the investigators recruited 1021 adults aged 18 to 64 years with TRD who had previously participated in 1 of 5 esketamine nasal spray “parent” studies prior to entering the SUSTAIN-3 study. These patients had also been receiving esketamine nasal spray treatment for a median of 46.9 months.1
For the current subgroup analysis, patients received esketamine nasal spray 56 mg or 84 mg twice a week during the induction phase and flexibly dosed esketamine nasal spray during the optimization and maintenance phase in addition to an oral antidepressant. Investigators evaluated clinician- and patient-reported disease severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire 9-Item (PHQ-9).1
The mean baseline MADRS and PHQ-9 scores at the start of the induction phase were 29.1 and 15.4, respectively—which, the investigators noted, were both consistent with moderate to severe diseases. Upon reevaluation at the end of the 4-week induction phase, the MADRS and PHQ-9 scores had changed to -12.9 (9.67) and -5.9 (5.77), respectively. The investigators also noted that these improvements were maintained throughout the optimization and maintenance phase.1
The percentage of patients who had reached MADRS and PHQ-9 remission—respectively defined as < 12 and < 5—at the time of their last assessment in the optimization and maintenance phase was 49.6% and 33.6%, respectively.1
“This subgroup analysis demonstrates that in adults with TRD, improvements in depressive symptoms with flexibly dosed [esketamine nasal spray] appear to be maintained with long-term treatment (up to 6.5 years),” the investigators concluded.
The research outlined in this poster presentation was contributed by John Zajecka, MD, of Rush University Medical Center in Chicago, Illinois, and colleagues from Janssen Research & Development, LLC, and Janssen Scientific Affairs, LLC.
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1. Zajecka J, Zaki N, Fu D, et al. Long-term efficacy of esketamine nasal spray dosed in accordance with US prescribing information in adults with treatment-resistant depression: a subgroup analysis of the SUSTAIN-3 study up to 6.5 years. Poster presentation. Presented at Psych Congress 2023. Accessed September 8, 2023. https://www.national.psychcongress.com/
2. A long-term safety study of esketamine nasal spray in treatment-resistant depression (SUSTAIN-3). ClinicalTrials.gov. Accessed September 8, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT02782104