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 the EQ-5D-5L than those on placebo plus antidepressant (69.2% vs 78.0%), alongside greater gains in quality of life and functioning.
Synthesized
Comparable studies
Other randomized controlled trials on esketamine for anxiety, most cited first.
Citations in the library
Cited by 11
- Esketamine Treatment for Depression in Adults: A PRISMA Systematic Review and Meta-Analysis. American Journal of Psychiatry March 1, 2025
- The Effects of Ketamine and Esketamine on Measures of Quality of Life in Major Depressive Disorder and Treatment-Resistant Depression: A Systematic Review. Journal of Affective Disorders August 1, 2025
- Advances in the study of NMDA receptors in depression pathogenesis and the antidepressant efficacy of their antagonists. Asian Journal of Psychiatry June 1, 2025
- Treatment-resistant depression and intranasal esketamine: Spanish clinical consensus on practical aspects The European Journal of Psychiatry May 2, 2025
- Long-term effectiveness and side-effects of intranasal esketamine in treatment-resistant depression: real-world, single-arm study of over 100 sessions. BJPsych Open January 23, 2026
and 6 more in the library
Cites 7
- Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study American Journal of Psychiatry May 21, 2019
- Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression JAMA Psychiatry June 5, 2019
- Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression JAMA Psychiatry December 27, 2017
- Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) The International Journal of Neuropsychopharmacology July 9, 2019
- Management of Treatment-Resistant Depression: Challenges and Strategies Neuropsychiatric Disease and Treatment 2020
and 2 more in the library