ObjectiveAtWoRC (Assessment in Work productivity and the Relationship with Cognitive symptoms) was an interventional, open-label, Canadian study (NCT02332954) designed to assess the association between cognitive symptoms and workplace productivity in working patients with major depressive disorder (MDD) receiving vortioxetine.MethodsEligible patients with MDD received vortioxetine (10–20 mg/day) and were assessed over 52 weeks at visits emulating a real-life setting (n = 199). Partial correlation between changes in patient-reported cognitive symptoms (20-item Perceived Deficits Questionnaire–Depression; PDQ-D-20) and workplace productivity (Work Limitations Questionnaire; WLQ) was assessed at 12 and 52 weeks. Additional assessments included depression severity, cognitive performance, and patient-reported functioning. Structural equations model (SEM) analyses assessed causal relationships between changes in measures of cognition and functioning over time, adjusted for improvements in depressive symptoms.ResultsStatistically significant improvements in all outcomes from baseline to week 52 were seen in the overall population and both subgroups (first treatment and switch). Response and remission rates were 77% and 56%, respectively. Improvements in PDQ-D-20 and WLQ productivity loss scores at weeks 12 and 52 were significantly correlated. SEM analyses found patient-rated cognitive symptoms (PDQ-D-20) at weeks 12 and 26 were significantly predictive (p < 0.05) of patient-reported functioning (Sheehan Disability Scale) at the subsequent visit. Depression severity and objectively measured cognitive performance did not significantly predict functional outcomes at any timepoint.ConclusionThese results demonstrate the long-term benefits of vortioxetine treatment in working patients with MDD and emphasize the strong association between cognitive symptoms and functioning in a real-world setting.

Background With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada. Methods Following their clinicians’ decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings. The primary outcome of global functioning was assessed with the Global Assessment of Functioning Scale (GAF) at 3-month intervals for 1 year. Secondary outcomes (social and occupational functioning and illness severity) and adverse drug reactions (ADR) were also assessed. Results A majority of the 169 evaluable patients were within the first 5 years of diagnosis (early phase). A linear mixed model analysis showed a significant main effect of time (Type III test p < 0.001) after adjusting for baseline GAF score, with a change in mean GAF scores from 49 at baseline to 61 at 12 months. No differences between early vs late phase were observed. Results on secondary outcome measures of function (Social and Occupational Functioning Scale) and illness severity (Clinical Global Impression-Severity Scale and Brief Psychiatric Rating Scale) were similar. Serious ADRs were observed in 29 (14.6%) patients and akathisia in 18 (9.1%) patients. At month-12, significant (≥7%) weight gain was observed in 25.7% ( n = 27/105) of patients. Conclusions Treatment with AOM is effective in improving symptoms and functioning in schizophrenia patients treated in regular clinical settings. Akathisia was infrequent while one quarter of patients gained clinically significant weight. Trial registration Unique identifier: NCT02131415 . First posted: 06 May 2014. Electronic supplementary material The online version of this article (10.1186/s12888-019-2103-x) contains supplementary material, which is available to authorized users.

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 patientreported cognitive symptoms (20-item Perceived Deficits Questionnaire ) 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.

Objective: To assess changes in workplace productivity and functioning in an open-label study in working patients receiving vortioxetine (10 to 20 mg/d) for major depressive disorder (MDD). Methods: Associations between items in the Work Limitations Questionnaire (WLQ), the Sheehan Disability Scale (SDS), and the Work Productivity and Activity Impairment (WPAI) questionnaire were assessed at 12 and 52 weeks by Pearson correlation coefficients. Results: Significant improvements were observed across all domains of workplace productivity and functioning after 12 and 52 weeks’ vortioxetine treatment. Strong correlations were seen between improvements in WLQ mental domains and WPAI presenteeism and SDS work/school items. Presenteeism showed stronger correlations with other workplace productivity measures than absenteeism. Conclusions: Presenteeism and absenteeism impact productivity in working patients with MDD. Vortioxetine confers long-term benefits across all workplace functioning domains.

Background: Anxiety symptoms are common in patients with major depressive disorder (MDD) and usually confer worse treatment outcomes. The long-term, open-label AtWoRC study in working patients with MDD treated with vortioxetine demonstrated a significant correlation between severity of anxiety symptoms and impaired work productivity. This analysis was undertaken to further explore clinical characteristics and treatment outcomes in patients with different levels of severity of anxiety symptoms at baseline. Methods: Post hoc analysis in 199 working patients with MDD treated with vortioxetine (10–20 mg/day), stratified by Generalized Anxiety Disorder 7-item (GAD-7) score at baseline [mild/moderate anxiety (GAD-7 ⩽14), n = 83; severe anxiety (GAD-7 ⩾15), n = 116]. Associations were examined between GAD-7 and other outcome assessment scores at baseline. Observed mean changes from baseline to week 52 were compared between groups. Results: Patients with severe anxiety had significantly worse depressive and cognitive symptoms, functioning, and work productivity at baseline than those with mild/moderate anxiety, but similar cognitive performance. Statistically significant improvements from baseline were seen for all outcomes after 52 weeks of vortioxetine treatment, with no significant differences observed between the two groups after adjustment for baseline anxiety scores. Conclusion: Treatment with vortioxetine was associated with long-term improvement in clinical symptoms and measures of work productivity in patients with MDD in a real-world setting, irrespective of severity of anxiety symptoms at the start of treatment.