Dataset Information

Anxiety symptoms in working patients with major depressive disorder treated with vortioxetine: associations with clinical and treatment outcomes in the AtWoRC study.

ABSTRACT:

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.

SUBMITTER: Chokka P

PROVIDER: S-EPMC8120527 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: Anhedonia is a common, persistent, and disabling phenomenon in treated adults with Major Depressive Disorder (MDD). Hitherto, relatively few antidepressant agents have been evaluated with respect to their effect on anhedonia in MDD. Methods: This is a post-hoc analysis of a primary study that sought to evaluate the sensitivity to change of the THINC-integrated tool (THINC-it) in MDD (ClinicalTrials.gov Identifier: NCT03053362). Adults meeting DSM-5 criteria for MDD with at least moderate depressive symptom severity [i.e., Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20] were eligible. Subjects were recruited between October 2017 and August 2018 in Toronto, Ontario at the Brain and Cognition Discovery Foundation. All subjects received open-label vortioxetine (10-20 mg/day, flexibly-dosed) for 8 weeks. Herein, the primary outcome of interest was the change from baseline to endpoint in the Snaith-Hamilton Pleasure Scale (SHAPS) total score, as well as the MADRS anhedonia factor. The mediational effects of improvements in anhedonia on general function and quality of life, as measured by the Sheehan Disability Scale (SDS) and the 5-Item World Health Organization Well-Being Index (WHO-5), were secondarily assessed. Results: A total of 100 subjects with MDD were enrolled in the primary study and began treatment with vortioxetine. Vortioxetine significantly improved anhedonia as evidenced by significant baseline to endpoint improvements in SHAPS and MADRS anhedonia factor scores (p < 0.0001). Improvements in the SHAPS and the MADRS anhedonia factor correlated with improvements in general function (i.e., SDS) and quality of life (i.e., WHO-5) (p < 0.0001). Notably, improvements in anhedonia were found to mediate the association between improvements in overall depressive symptom severity (i.e., MADRS total score) and social functioning (i.e., social life component of the SDS) (p = 0.026). Conclusion: The unmet need in depression is to improve patient functioning and other patient-reported outcomes (e.g., quality of life). Antidepressant interventions capable of attenuating anhedonia as well as cognitive dysfunction in MDD may help in this regard, as improvement in these domains have been associated with improvement in psychosocial function and quality of life.