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
Carol Jamieson, Vanina Popova, Ella Daly, Kimberly Cooper, Wayne C. Drevets, Heather Rozjabek, Jaskaran Singh
Health and Quality of Life Outcomes May 8, 2023 DOI: 10.1186/s12955-023-02113-1 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Phase 3, randomized, double-blind, short-term flexibly dosed study Peer reviewed |
|---|---|
| Sample size | 223 |
| Population | Patients aged 18-64 years with treatment-resistant depression |
| Interventions | Esketamine nasal spray oral antidepressant |
| Duration | 28-day intervention |
| Topics | Anxiety Depression Esketamine |
| Keywords | Depression economics Nasal spray Antidepressant Eq-5d Pharmacology Nasal administration Nursing Disease |
| Citations | 18 |
| Registration | NCT02418585 |
| Key points | Esketamine nasal spray plus an oral antidepressant led to greater improvements in health-related quality of life and functioning at day 28 compared to placebo plus an antidepressant. |
Abstract
Background: 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).
Methods: 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.
Results: 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]).
Conclusions: Greater improvements in HRQoL and health status were observed among patients with TRD treated with ESK + AD vs. AD + PBO.
Trial Registration: ClinicalTrials.gov Identifier: NCT02418585.
In the evidence
This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.
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At day 28, fewer patients on esketamine plus antidepressant reported impairment on the anxiety/depression dimension of a quality-of-life measure compared with placebo plus antidepressant.
Synthesized
Comparable studies
Other randomized controlled trials on esketamine for anxiety, most cited first.