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Randomized Controlled Trial
. 2023 May 8;21(1):40.
doi: 10.1186/s12955-023-02113-1.

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  1 , Vanina Popova  2 , Ella Daly  3 , Kimberly Cooper  4 , Wayne C Drevets  5 , Heather M Rozjabek  6 , Jaskaran Singh  4   7
Affiliations
Randomized Controlled Trial

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 et al. Health Qual Life Outcomes. .

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.

Keywords: Esketamine; European Quality of Life Group; Five Dimension; Five Level (EQ-5D-5L); Health-related quality of life (HRQoL); Major depressive disorder; Sheehan Disability Scale; Treatment-resistant depression.

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Conflict of interest statement

Ms. Jamieson, Dr. Popova, Ms. Cooper, Dr. Drevets, and Dr. Rozjabek are employees of Janssen Research & Development, LLC and may hold company stock and/or stock options. Both Drs. Singh and Daly worked on the clinical development program of esketamine for treatment-resistant depression during their employment by Janssen Research & Development, LLC; Dr. Singh is currently employed by Neurocrine Biosciences, San Diego, CA; Dr. Daly is currently a self-employed medical consultant.

Figures

Fig. 1
Fig. 1
EQ-5D-5L individual dimensions – relative risk for problems. AD, antidepressant; CI, confidence interval; EQ-5D-5L, European Quality of Life-5 Dimension-5 Level; ESK, esketamine
Fig. 2
Fig. 2
Mean (SE) HSI and EQ-VAS changes over time. AD + PBO, oral antidepressant plus placebo nasal spray; EQ-VAS, EuroQol Visual Analogue Scale; ESK + AD, esketamine nasal spray plus oral antidepressant; HSI, health status index; SE, standard error. For HSI; A: 18–29-year-old healthy adult; B: Depressive disorder; C: Senility without psychosis. The 3 horizontal lines indicate preference-based EQ-5D-5L index scores for a healthy 18–29-year-old individual, a patient with depressive disorder, and a senile patient without psychosis. These values have been added to visualize the changes observed in the current study and put them into clinical context. For EQ-VAS scores; Higher EQ-VAS scores indicate better health. A: general adult population in the US; B: patients with any cancer; C: patient with first episode or a new recurrent episode of depression. The 3 horizontal lines A, B, and C indicate EQ-VAS scores in the general adult population in the US, patients with any cancer, and a patient with first episode or a new recurrent episode of depression
Fig. 3
Fig. 3
Change in the SDS score among patients included in the study using MMRM. AD + PBO, oral antidepressant plus placebo nasal spray; CI, confidence interval; ESK + AD, esketamine nasal spray plus oral antidepressant; LSM, least square mean; MMRM, mixed-effects model using repeated measures; SDS, Sheehan Disability Scale; SE, standard error. aTest for treatment effect is based on mixed model for repeated measures (MMRM) with change from baseline as the response variable and the fixed effect model terms for treatment), day, country, class of oral antidepressant (SNRI or SSRI), and treatment-by-day and baseline value as a covariate. A negative difference favors the ESK + AD group. Note: SDS total score ranges from 0 to 30; a higher score indicates greater impairment. Negative change in score indicates improvement
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