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Psych Congress  

Personalized Goal Attainment After a Switch to Vortioxetine in a Phase 4 Open-Label Trial in Adults With Major Depressive Disorder (MDD): Health Outcomes and Progress Toward Functional Recovery

Sagar Parikh, MD – University of Michigan Depression Center; Debra Lawrence, MS, PhD – Takeda Pharmaceuticals; Sara Sarkey, PhD – Takeda Pharmaceuticals; Anna Eramo, MD – Lundbeck LLC; Maelys Touya, PharmD MS – Lundbeck LLC
The study was funded by Takeda Pharmaceuticals U.S.A., Inc., and Lundbeck LLC.Medical writing assistance, provided by Syneos Health, was supported by Takeda Pharmaceuticals U.S.A., Inc., and Lundbeck LLC.

This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Traditional measures of MDD treatment response may miss meaningful changes for individual patients. A novel approach using a Goal Attainment Scale (GAS) Adapted for Depression (GAS-D) provides a framework to measure progress toward personalized treatment goals.

This Phase 4 open-label trial evaluated real-world effectiveness of the antidepressant vortioxetine on patients’ ability to achieve pre-identified treatment goals. The functional impact to patients and health outcomes results are also presented.

Patients with MDD, requiring a switch in antidepressant treatment, were given flexible-dose vortioxetine (10-20 mg) for 12 weeks. Successful attainment of pre-identified goals (primary outcome) was demonstrated by a GAS-D score of ≥50 at week 12.

Assessments of quality of life/life satisfaction (Q-LES-Q), well-being (WHO-5), workplace functioning (LEAPS), and healthcare resource utilization were completed.

Approximately 86% of patients (106/123) completed treatment—82.8% women, 69.2% white, mean age 45 years. For the primary endpoint, 57.8% of patients achieved a GAS-D score of ≥50 at week 12. Significant improvements (p<0.001) from baseline were noted at weeks 6 and 12 for WHO-5 and at week 12 for LEAPS (mean decrease, 5.7 points), Q-LES-Q total (mean increase, 1.13 points), and Q-LES-Q subscale scores assessing physical health/activity, feelings, work, household duties, leisure activities, social relations, and general activities. No significant increases in number of healthcare provider visits, hospitalizations, or sick days were observed. 

A substantial proportion of vortioxetine-treated patients achieved their personalized treatment goals at week 12. Functional recovery indicators showed significant improvement without an increase in resource utilization.

Clinical outcomes are presented in a separate abstract.

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