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119 Assessment of Health-Related Quality of Life and Health Status in Patients with Treatment-resistant Depression

Published online by Cambridge University Press:  24 April 2020

Carol Jamieson
Affiliation:
Director, Health Economics Strategic Market Access, Janssen Research and Development LLC, San Francisco, California, USA
Vanina Popova
Affiliation:
Director, BE Central Nervous, Janssen Research and Development LLC, Antwerp, Belgium
Ella Daly
Affiliation:
Therapeutic Area Leader, Mood Disorders, Esketamine, Janssen Research and Development LLC, New Jersey, USA
Kimberly Cooper
Affiliation:
Statistics: Associate Director, Clinical Biostatistics, Janssen Research and Development LLC, Greater Philadelphia, Pennsylvania, USA
Madhukar H. Trivedi
Affiliation:
Psychiatry: Founding Director of Center of Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, Texas, USA
Wayne Drevets
Affiliation:
VP, Disease Area Leader, Mood Disorders, Janssen Research and Development LLC, Greater Philadelphia, Pennsylvania, USA
Jaskaran Singh
Affiliation:
Psychiatry: Senior Director, Neuroscience, Janssen Research and Development LLC, New Jersey, USA
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Abstract:

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Objective:

To assess health-related quality of life (HRQoL) and health status of patients with treatment resistant depression (TRD), treated with esketamine nasal spray+oral antidepressant (ESK+AD) vs oral antidepressant+placebo nasal spray (AD+PBO) using European Quality of Life Group-5-Dimension-5-Level (EQ-5D-5L). The EQ-5D-5L descriptive system consists of five domains relevant for patients with depression (mobility, self-care, usual activities, pain, anxiety/depression) and the EQ-Visual Analogue Scale (EQ-VAS).

Methods:

Data from TRANSFORM-2 (NCT02418585), a randomized, double-blind short-term study were analyzed. Patients (18-64 years inclusive) with TRD were included. Patient reported health status change using EQ-5D-5L and EQ-VAS was measured from baseline to end of 4-week induction phase (endpoint). Each domain of EQ-5D-5L included 5 levels of perceived problems (L1: no problems; L5: extreme problems).

Results:

Full analysis set included 223 patients (ESK+AD: 114; AD+PBO: 109). At endpoint, mean (SD) change in health status index was 0.288 (0.2317) for ESK+AD group and 0.231 (0.2506) for AD+PBO group with higher score reflecting higher levels of functioning. At endpoint, percentage of patients reporting problems (grouped L2-L5 responses for each dimension) in ESK+AD vs AD+PBO group: mobility (13.5% vs 25.7%), self-care (16.2% vs 30.5%), usual activities (55.0% vs 71.4%), pain (38.7% vs 52.4%), and anxiety/depression (71.2% vs 78.1%). Mean (SD) change in EQ-VAS score at endpoint was 29.1 (26.32) for ESK+AD and 20.9 (26.60) for AD+PBO group.

Conclusion:

Greater improvement in HRQoL and health status using EQ-5D-5L and EQ-VAS was observed among patients with TRD treated with ESK+AD vs AD+PBO.

Funding Acknowledgements:

This study was sponsored by Janssen Research and Development, LLC.

Type
Abstracts
Copyright
© Cambridge University Press 2020