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Clinical Trial
. 2019 Jun;24(3):338-347.
doi: 10.1017/S1092852918000913. Epub 2018 May 24.

Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC): primary analysis from a Canadian open-label study of vortioxetine in patients with major depressive disorder (MDD)

Affiliations
Clinical Trial

Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC): primary analysis from a Canadian open-label study of vortioxetine in patients with major depressive disorder (MDD)

Pratap Chokka et al. CNS Spectr. 2019 Jun.

Abstract

Objective: The Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC) study aimed to assess the association between cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a major depressive episode (MDE).

Methods: Patients diagnosed with major depressive disorder (MDD) and treated with vortioxetine independently of study enrollment were assessed over 52 weeks at visits that emulated a real-life setting. Patients were classified as those receiving vortioxetine as the first treatment for their current MDE (first treatment) or having shown inadequate response to a previous antidepressant (switch). The primary endpoint was the correlation between changes in patient-reported cognitive symptoms (20-item Perceived Deficits Questionnaire [PDQ-D-20]) and changes in work productivity loss (Work Limitations Questionnaire [WLQ]) at week 12. Additional assessments included changes in symptom and disease severity, cognitive performance, functioning, work loss, and safety.

Results: In the week 12 primary analysis, 196 eligible patients at 26 Canadian sites were enrolled, received at least one treatment dose, and attended at least one postbaseline study visit. This analysis demonstrated a significant, strong correlation between PDQ-D-20 and WLQ productivity loss scores (r=0.634; p<0.001), and this correlation was significant in both first treatment and switch patients (p<0.001). A weaker correlation between Digit Symbol Substitution Test and WLQ scores was found (r=-0.244; p=0.003).

Conclusion: At 12 weeks, improvements in cognitive dysfunction were significantly associated with improvements in workplace productivity in patients with MDD, suggesting a role for vortioxetine in functional recovery in MDD.

Keywords: Cognitive dysfunction; functional impairment; major depressive disorder; real life; vortioxetine; work productivity.

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Figures

Figure 1
Figure 1
Study design of the AtWoRC study. MDE=major depression episode
Figure 2
Figure 2
Patient disposition. *“Completed” refers to those who attended the Week 12 visit. “Discontinued” refers to treatment discontinuation before Week 12. †Ongoing analysis. APTS=all patients treated set; FAS=full analysis set
Figure 3
Figure 3
Response and remission rates at Week 12 (OC). FAS=Full Analysis Set; OC=observed cases

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