Effectiveness of intranasal esketamine in the treatment of patients with treatment-resistant depression: an observational study based on data collected in a Spravato treatment program at the Institute of Living, Hartford, CT.

Intranasal esketamine, approved by the FDA in 2019 for treatment-resistant depression (TRD), showed real-world effectiveness in a clinical setting in Hartford, Connecticut. In a sample of 50 patients whose moderate to severe baseline depressive symptoms were measured with the Montgomery-Asberg Depression Rating Scale (MADRS), symptoms reduced to the mild range after 4 weeks, and this improvement was sustained over 16 weeks of treatment. Adverse effects were transient and generally mild, with dissociation and sedation being most common; there were no safety events, misuse, or dependence, and very few discontinuations due to tolerability. The findings indicate that intranasal esketamine augmentation therapy is safe and effective in routine clinical practice.

Study at a glance

Abstract

Major Depressive Disorder is a common and disabling psychiatric illness whose pharmacological treatment options have historically been characterized by relatively low response rates. "Treatment-resistant depression" has emerged to describe patients whose depressive symptoms fail to respond to multiple courses of oral antidepressant medications. In 2019, the FDA approved intranasal esketamine as augmentation to an oral antidepressant in patients with treatment-resistant depression (TRD). While intranasal esketamine's efficacy was demonstrated in Janssen pharmaceutical's drug development program, publications on its real-world use have shown varying degrees of effectiveness. We aim to assess intranasal esketamine's effectiveness in a real-world clinical setting in Hartford, Connecticut, and are among the first to do so in an American sample using the Montgomery-Asberg Depression Rating Scale (MADRS), the same outcome measure used in the clinical trials where efficacy was established. In this analysis, a sample of 50 patients were enrolled in an intranasal esketamine treatment program at the Institute of Living (IOL) in Hartford, Connecticut. Information for these patients was obtained through retrospective analysis of the electronic health record. Descriptive statistics were used to analyze symptom severity and outcomes, using the Montgomery-Asberg Depression Rating Scale (MADRS) score at baseline and over 16 weeks of treatment. Assessment showed that moderate to severe baseline symptoms of depression were reduced to the mild range after 4 weeks and this effect was sustained over 16 weeks of treatment. Adverse effects were transient and generally mild (dissociation and sedation being the most common), with no safety events, and very few discontinuations related to tolerability. Results of this analysis demonstrate real-world effectiveness of intranasal esketamine as augmentation therapy in treatment resistant depression. The medication was well tolerated, with no safety events, misuse or dependence. While results demonstrating the efficacy of intranasal esketamine in patients with TRD were observed in the clinical trial studies, this analysis shows intranasal esketamine treatment to be safe and effective in a real-world clinical setting.