Major Depressive Disorder
New Insights on Generalized Anxiety and Resiliency at the Workplace
Clinical Study Title:
Efficacy of vortioxetine in working patients with generalized anxiety disorder
Clinical Study Abstract:
- Background: Vortioxetine is an approved antidepressant that has shown positive effects on anxiety symptoms in patients with generalized anxiety disorder (GAD).
- Methods: A post hoc analysis was undertaken to evaluate the efficacy of vortioxetine in patients with GAD who are working and/or pursuing an education. NCT00744627 was an acute GAD study, with 301 patients randomized to vortioxetine 5 mg or placebo for 8 weeks. Efficacy measures included the Hamilton Anxiety Rating Scale (HAM–A) total score, response/remission, global functioning (Sheehan Disability Scale [SDS]), and quality of life (Short Form–36 Health Survey). NCT00788034 was a GAD relapse-prevention study with 687 patients treated open-label with vortioxetine 5 or 10 mg for 20 weeks, after which subjects in remission were randomized to fixed-dose of vortioxetine (5 or 10 mg) or placebo for at least 24 weeks. Time-to-relapse analyses were done for those working and/or pursuing an education and in the full analysis set.
- Results: In NCT00744627, the effect of vortioxetine versus placebo on HAM–A total score was –4.3 (P=0.0005) in working subjects (60% of total), while the effect in the total population was –3.8 (P=0.0001). The effect was greatest in subjects in professional (–4.5; P=0.0130) and associate professional positions (–7.6; P=0.0086); in NCT00788034, working subjects (69% of total) randomly allocated to placebo were significantly more likely to relapse than those treated with vortioxetine (hazard ratio [HR]=2.9; P<0.001), while in the total population HR=2.7 (P<0.0001).
- Conclusions: The beneficial effects of vortioxetine on anxiety symptoms, functioning, and quality of life are greater in adults with GAD who are working and/or pursuing an education versus the full GAD study population.
Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2017:1-9. doi: 10.1017/S1092852917000761. [Epub ahead of print].
Professor of Psychiatry and Pharmacology
“Thus, we hypothesized that we would observe a greater effect with vortioxetine in working adults with GAD—not only on anxiety symptoms but also in global functioning and quality of life.”
Vortioxetine is an approved antidepressant that has a multimodal mechanism of action. In previous work, we observed a more pronounced effect with vortioxetine in the working adult MDD population—both on depressive symptoms and cognitive functioning; and, the greatest effects were observed in patients who held jobs in professional positions, such as managers and associate managers. Susceptibility to anxiety, in particular, at the workplace may be influenced by a number of different factors, including the individual’s place within the organizational chart of the company; presumably, those higher up in the organization may have a stronger internal locus of control serving as resiliency for anxiety, as reflected by observations from the Whitehall II study.
GAD and MDD are highly comorbid. Each is associated with workplace impairment independently, and when both MDD and GAD are present, data suggest the reduction in overall work productivity may be significant. Positive effects have been seen with vortioxetine on anxiety symptoms in patients with GAD, in both the short and long term. Additionally, the effect of vortioxetine on cognitive functioning in patients with MDD has been clearly established. Thus, we hypothesized that we would observe a greater effect with vortioxetine in working adults with GAD—not only on anxiety symptoms but also in global functioning and quality of life. Indeed, the results of this analysis demonstrated a more pronounced, multidomain effect that was seen not only in patients with acute GAD after 8 weeks of treatment but also in a remitted GAD population, where vortioxetine therapy had been maintained up to 48 weeks after remission. The mechanism(s) mediating the anxiolytic effects of vortioxetine in adults with GAD and MDD are unknown; however, several hypotheses have been advanced. The effect of vortioxetine on cognitive functioning in MDD is well established and may also play a role for working patients with GAD; however, the GAD studies in the present analysis did not specifically assess the effect on cognitive functioning, and, because these were post hoc analyses, findings should be considered hypothesis-generating, for future research.
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