Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant

• Published in: Health and quality of life outcomes Vol. 21; no. 1; p. 40
• Main Authors: Jamieson, Carol, Popova, Vanina, Daly, Ella, Cooper, Kimberly, Drevets, Wayne C, Rozjabek, Heather M, Singh, Jaskaran
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 08.05.2023; BioMed Central; BMC
• Subjects: Antidepressants; Antidepressive Agents - therapeutic use; Anxiety; Care and treatment; Depression; Diagnosis; Dosage and administration; Esketamine; European Quality of Life Group; FDA approval; Five Dimension; Five Level (EQ-5D-5L); Health aspects; Health Status; Health-related quality of life (HRQoL); Humans; Major depressive disorder; Mental depression; Mental health; Middle Aged; Nasal Sprays; Patients; Quality assessment; Quality of Life; Questionnaires; Remission (Medicine); Social life & customs; Statistical analysis; Suicides & suicide attempts; United States; United States > US; Esketamine; Five Dimension; Sheehan Disability Scale; European Quality of Life Group; Five Level (EQ-5D-5L); Treatment-resistant depression; Health-related quality of life (HRQoL); Major depressive disorder
• ISSN: 1477-7525; 1477-7525
• DOI: 10.1186/s12955-023-02113-1

Patients with treatment-resistant depression (TRD) report significant deficits in physical and mental health, as well as severely impaired health-related quality of life (HRQoL) and functioning. Esketamine effectively enhances the daily functioning in these patients while also improving their depressive symptoms. This study assessed HRQoL and health status of patients with TRD, who were treated with esketamine nasal spray and an oral antidepressant (ESK + AD) vs. placebo nasal spray and an AD (AD + PBO). Data from TRANSFORM-2, a phase 3, randomized, double-blind, short-term flexibly dosed study, were analyzed. Patients (aged 18-64 years) with TRD were included. The outcome assessments included the European Quality of Life Group, Five Dimension, Five Level (EQ-5D-5L), EQ-Visual Analogue Scale (EQ-VAS), and Sheehan Disability Scale (SDS). The health status index (HSI) was calculated using EQ-5D-5L scores. The full analysis set included 223 patients (ESK + AD: 114; AD + PBO: 109; mean [SD] age: 45.7 [11.89]). At Day 28, a lower percentage of patients reported impairment in the ESK + AD vs. AD + PBO group in all five EQ-5D-5L dimensions: mobility (10.6% vs. 25.0%), self-care (13.5% vs. 32.0%), usual activities (51.9% vs. 72.0%), pain/discomfort (35.6% vs. 54.0%), and anxiety/depression (69.2% vs. 78.0%). The mean (SD) change from baseline in HSI at Day 28 was 0.310 (0.219) for ESK + AD and 0.235 (0.252) for AD + PBO, with a higher score reflecting better levels of health. The mean (SD) change from baseline in EQ-VAS score at Day 28 was greater in ESK + AD (31.1 [25.67]) vs. AD + PBO (22.1 [26.43]). The mean (SD) change in the SDS total score from baseline to Day 28 also favored ESK + AD (-13.6 [8.31]) vs. AD + PBO (-9.4 [8.43]). Greater improvements in HRQoL and health status were observed among patients with TRD treated with ESK + AD vs. AD + PBO. ClinicalTrials.gov Identifier: NCT02418585.