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      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

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          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.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12955-023-02113-1.

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          Most cited references41

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          Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire.

          R L Spitzer, K Kroenke, J. Williams (1999)
          The Primary Care Evaluation of Mental Disorders (PRIME-MD) was developed as a screening instrument but its administration time has limited its clinical usefulness. To determine if the self-administered PRIME-MD Patient Health Questionnaire (PHQ) has validity and utility for diagnosing mental disorders in primary care comparable to the original clinician-administered PRIME-MD. Criterion standard study undertaken between May 1997 and November 1998. Eight primary care clinics in the United States. Of a total of 3000 adult patients (selected by site-specific methods to avoid sampling bias) assessed by 62 primary care physicians (21 general internal medicine, 41 family practice), 585 patients had an interview with a mental health professional within 48 hours of completing the PHQ. Patient Health Questionnaire diagnoses compared with independent diagnoses made by mental health professionals; functional status measures; disability days; health care use; and treatment/referral decisions. A total of 825 (28%) of the 3000 individuals and 170 (29%) of the 585 had a PHQ diagnosis. There was good agreement between PHQ diagnoses and those of independent mental health professionals (for the diagnosis of any 1 or more PHQ disorder, kappa = 0.65; overall accuracy, 85%; sensitivity, 75%; specificity, 90%), similar to the original PRIME-MD. Patients with PHQ diagnoses had more functional impairment, disability days, and health care use than did patients without PHQ diagnoses (for all group main effects, P<.001). The average time required of the physician to review the PHQ was far less than to administer the original PRIME-MD (<3 minutes for 85% vs 16% of the cases). Although 80% of the physicians reported that routine use of the PHQ would be useful, new management actions were initiated or planned for only 117 (32%) of the 363 patients with 1 or more PHQ diagnoses not previously recognized. Our study suggests that the PHQ has diagnostic validity comparable to the original clinician-administered PRIME-MD, and is more efficient to use.
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            The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10.

            D Sheehan, Y Lecrubier, K Sheehan … (1998)
            The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-IV and ICD-10 psychiatric disorders. With an administration time of approximately 15 minutes, it was designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in nonresearch clinical settings. The authors describe the development of the M.I.N.I. and its family of interviews: the M.I.N.I.-Screen, the M.I.N.I.-Plus, and the M.I.N.I.-Kid. They report on validation of the M.I.N.I. in relation to the Structured Clinical Interview for DSM-III-R, Patient Version, the Composite International Diagnostic Interview, and expert professional opinion, and they comment on potential applications for this interview.
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              Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report

              A Rush, Madhukar Trivedi, Stephen R Wisniewski … (2006)
              This report describes the participants and compares the acute and longer-term treatment outcomes associated with each of four successive steps in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.
              Article 0 comments Cited 767 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Carol Jamieson: cjamies2@its.jnj.com
                Journal
                Journal ID (nlm-ta): Health Qual Life Outcomes
                Journal ID (iso-abbrev): Health Qual Life Outcomes
                Title: Health and Quality of Life Outcomes
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1477-7525
                Publication date (Electronic): 8 May 2023
                Publication date PMC-release: 8 May 2023
                Publication date Collection: 2023
                Volume: 21
                Electronic Location Identifier: 40
                Affiliations
                [1 ]Janssen Research & Development, LLC, Milpitas, CA 95035 USA
                [2 ]GRID grid.419619.2, ISNI 0000 0004 0623 0341, Janssen Research & Development, ; Beerse, BE Belgium
                [3 ]GRID grid.497530.c, ISNI 0000 0004 0389 4927, Janssen Scientific Affairs, LLC, ; Titusville, NJ USA
                [4 ]GRID grid.497530.c, ISNI 0000 0004 0389 4927, Janssen Research & Development, LLC, ; Spring House, PA USA
                [5 ]GRID grid.497530.c, ISNI 0000 0004 0389 4927, Janssen Research & Development, LLC, ; San Diego, CA USA
                [6 ]GRID grid.497530.c, ISNI 0000 0004 0389 4927, Janssen Research & Development, LLC, ; Raritan, NJ USA
                [7 ]GRID grid.429755.8, ISNI 0000 0004 0410 4376, Present Address: Neurocrine Biosciences, ; San Diego, CA USA
                Article
                Publisher ID: 2113
                DOI: 10.1186/s12955-023-02113-1
                PMC ID: 10169482
                PubMed ID: 37158911
                SO-VID: 47e511e3-94db-4a80-8e2b-06e6926eac9f
                Copyright © © Janssen Research & Development, LLC 2023
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 3 November 2022
                Date accepted : 20 March 2023
                Funding
                Funded by: Janssen Research & Development, LLC, United States
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © BioMed Central Ltd., part of Springer Nature 2023

                ScienceOpen disciplines: Health & Social care
                Keywords: european quality of life group,five dimension,five level (eq-5d-5l),esketamine,health-related quality of life (hrqol),major depressive disorder,sheehan disability scale,treatment-resistant depression
                Data availability:
                ScienceOpen disciplines: Health & Social care
                Keywords: european quality of life group, five dimension, five level (eq-5d-5l), esketamine, health-related quality of life (hrqol), major depressive disorder, sheehan disability scale, treatment-resistant depression

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