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Observational Study
. 2021 Mar 15:283:115-122.
doi: 10.1016/j.jad.2020.11.124. Epub 2020 Nov 30.

Real-world evidence from a European cohort study of patients with treatment resistant depression: Baseline patient characteristics

K Heerlein  1 , A H Young  2 , C Otte  3 , T Frodl  4 , G Degraeve  5 , W Hagedoorn  6 , A J Oliveira-Maia  7 , V Perez Sola  8 , S Rathod  9 , G Rosso  10 , P Sierra  11 , J Morrens  12 , G Van Dooren  12 , Y Gali  12 , G Perugi  13
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Free article
Observational Study

Real-world evidence from a European cohort study of patients with treatment resistant depression: Baseline patient characteristics

K Heerlein et al. J Affect Disord. .
Free article

Abstract

Background: Treatment resistant depression (TRD; failure to respond to ≥2 treatments) affects ~20% of patients with major depressive disorder (MDD). Real-world data could help describe patient characteristics and TRD disease burden, to assess the unmet needs of TRD patients in Europe.

Methods: This observational study collected data from adults with moderate to severe TRD initiating a new treatment for depression, according to local standards of care. At baseline, socio-demographic characteristics, medical history, prior and current treatments were recorded. Disease severity, health-related quality of life (HRQoL), functionality and productivity were assessed.

Results: Overall, 411 eligible patients were enrolled across seven European countries. Mean (standard deviation [SD]) patient age was 51.0 (10.8) years; 62.3% were female. Long-term sick leave was reported by 19.0% of patients; 30.2% were unemployed. The mean (SD) duration of the current episode was 2.6 (3.9) years. At baseline, mean (SD) HRQoL scores for EuroQoL 5-dimension 5-level (UK tariff) and EQ-Visual Analog Scale were 0.41 (0.25) and 41.1 (18.7), respectively. The Work Productivity and Activity Impairment questionnaire demonstrated mean (SD) absenteeism of 57.0% (44.9%) and presenteeism of 54.7% (29.5%); mean (SD) overall work impairment was 60.5% (29.9%).

Limitations: Key limitations are small cohort size, absence of a control group and generalizability to countries with different healthcare models.

Conclusions: TRD patients had a high disease burden, low HRQoL and reduced function and productivity, with a substantial proportion unable to work. This demonstrates an unmet treatment need in TRD patients that, if addressed, could reduce the heavy personal and societal burden.

Keywords: Disease burden; Health-related quality of life; Major depressive disorder; Observational study; Patient-reported outcomes; Socio-economic status.

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