A Real-World Cohort Study on the Effectiveness, Tolerability and Acceptability of Esketamine Intra-Nasal Spray in Young Adults with Treatment-Resistant Depression

Abstract

This study is a secondary analysis related to the study of Pape & Ruhe and the Esketamine Nasal-Spray Consortium (ENC-NL) with the preliminary title “Effectiveness and Acceptability of Intra-Nasal Esketamine: Evidence from Real-World Cohort Study”. Despite major depressive disorder (MDD) being most prevalent among individuals aged 18 to 34 years (1,2), research on antidepressant treatment in this age group remains scarce and often lack methodological rigor (3,4). In adolescents, efficacy of antidepressants tend to be lower compared to adults and also side-effects profiles differ between age-groups (3,5). Given that both social and biological maturation continue into the third decade of life (6), young adults are likely to face similar problems in the treatment of depression as adolescents. Therefore, this open-label naturalistic cohort study aims to assess the effectiveness of esketamine augmentation therapy on depressive symptoms, quality of life, acceptability and side-effects in young patients up to 30 years with treatment-resistant depression. Data on intra-nasal (IN) esketamine for treatment resistant depression is collected in the Netherlands by the ENC-NL since start of the compassionate use program in 2019. Data is requested at the ENC-NL for the purpose of this study. Data was collected at a total of 26 specialized healthcare centers in the Netherlands. All patients participating had a history of inadequate response to treatment with three different antidepressant regimes, one of which must have been an augmentation strategy. All patients were somatically screened before start of treatment. Treatment with IN esketamine was initiated at 28 mg and could be titrated up to 84 mg during the first four weeks. After that, a fixed dosage was given and data was collected until up to six months. Outcomes were measured on the Montgomery-Asberg Depression Rating Scale, the Inventory of Depressive Symptomatology – Self Report scale, the EQ-5D-5L scale, the WHO Disability Assessment Schedule 2.0 scale, the Ketamine side effect tool and vital signs were assessed. Analysis will be conducted with Linear Mixed Models in R.

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