Real-World Effectiveness: New MDD Treatment

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Lundbeck announced positive results from the Real-World Effectiveness of Vortioxetine (RELIEVE) study evaluating vortioxetine for the treatment of major depressive disorder (MDD) and how it affected their everyday lives.

“The strong results from this trial show that patients treated with [vortioxetine] experience a significant improvement in overall functioning over a substantial period of 6 months. I think it is an interesting aspect that this study specifically shows an effect of [vortioxetine] on family, work, and social life functioning. At the end of the day, we want to be able to restore brain health, so people can be at their best,” said Johan Luthman, Executive Vice President for Research and Development at Lundbeck.¹

While the mechanism of vortioxetine is not fully understood, it is an inhibitor of serotonin (5-HT) reuptake. It is also an agonist at 5-HT1A receptors; a partial agonist at 5-HT1B receptors; and an antagonist at 5-HT3, 5-HT1D, and 5-HT7 receptors. Vortioxetine is perhaps the first of its kind with this combination of pharmacodynamic activity.

A total of 994 participants were evaluated for depressive symptoms as measured by the Sheehan Disability Scale (SDS), a tool that assesses impairment patients find in the following areas of their lives: family, social life, home responsibilities, and work/school. Eligible participants included patients with MDD initiating treatment with vortioxetine or switching from another antidepressant to treat a current major depressive episode.

Data were collected at routine clinic visits at baseline, 3 months, and 6 months. Analysis showed significant and meaningful improvements by 6.9 points and 8.6 points respectively after 3 and 6 months on the SDS when compared to prior antidepressant treatment.

The secondary and exploratory endpoints were also met, with a 0.13 improvement on the EQ-5D utility score measuring health-related quality of life for participants, and a 7.4 decrease in depressive symptoms from baseline as measured by the PHQ-9 (Patient Health Questionnaire-9) scale.

The RELIEVE study provides novel insights, as its focus was on patient self-assessment of daily functioning and their own experiences with improvement after treatment with vortioxetine.

Full results will be published in a peer-reviewed scientific journal later in 2021 and presented at future medical conferences. At this time, however, caution is needed, and further research is warranted.

Reference

1. Lundbeck. Vortioxetine significantly improves overall functioning in a global real-world study in Major Depressive Disorder. News release. April 22, 2021. https://news.cision.com/h--lundbeck-a-s/r/vortioxetine-significantly-improves-overall-functioning-in-a-global-real-world-study-in-major-depres,c3330732