Using the Goal Attainment Scale adapted for depression to better understand treatment outcomes in patients with major depressive disorder switching to vortioxetine: a phase 4, single-arm, open-label, multicenter study

Abstract

Background: Major depressive disorder (MDD) is the leading cause of disability worldwide. Response to pharmacologic treatment is generally evaluated by traditional clinician- and patient-reported rating scales. Assessing therapeutic efficacy using the Goal Attainment Scale offers a complementary measure that focuses on recovery-oriented outcomes that patients consider valuable and vital to their well-being. This study aimed to examine outcomes using the Goal Attainment Scale adapted for depression (GAS-D).

Methods: A phase 4, single-arm, open-label, multicenter study enrolled patients with MDD who were switching antidepressant medication. Patients received vortioxetine 10-20 mg over 12 weeks. Three specific, measurable, attainable, relevant, and time-bound goals were collaboratively set by patients with their clinicians. One goal was determined by the patient's self-defined objectives; 2 were related to predefined domain categories. Prespecified domains included psychological, motivational, emotional, physical/functional, and cognitive categories. The primary endpoint was the proportion of patients who achieved a GAS-D score ≥ 50 at week 12. Secondary and exploratory endpoints included changes from baseline in several clinical and patient-reported measures of depression and cognitive function. Safety and tolerability were also assessed.

Results: At week 12, of the 122 adults participating in the study, 57.8% achieved a GAS-D score ≥ 50. Depression severity, cognitive function, cognitive performance, well-being, employment, and quality of life also significantly improved. Treatment response and remission rates were 65 and 40%, respectively. Vortioxetine was well tolerated, with adverse events consistent with product labeling.

Conclusions: A majority of patients with MDD switching to vortioxetine achieved their treatment goals, including improvement in specific functional outcomes relating to physical and emotional goals, as assessed by the GAS-D and standard patient- and clinician-reported measures. When assayed for convergent validity in a separate analysis, changes in goal scores on the GAS-D were statistically significantly correlated with multiple commonly used clinical measures of depression assessed in this study. The GAS-D approach provides a new patient-centric paradigm for the collaborative development and assessment of progress toward meaningful treatment goals, contributing to a comprehensive evaluation of treatment outcomes in patients with MDD. Longer studies against a control intervention are justified.

Trial registration: ClinicalTrials.gov identifier: NCT02972632 . Registered 21 November 2016.

Keywords: Goal achievement; Goal attainment; Major depressive disorder; Vortioxetine.

Conflict of interest statement

MM and SS are employees of Takeda Pharmaceuticals U.S.A., Inc. AE and CF were employees of Lundbeck, LLC, at the time of this study. SVP is a consultant to Takeda and Sunovion, has a research contract with Assurex Health, Inc., and owns shares in Mensante Corporation.

© 2021. The Author(s).

Figures

Fig. 1

Goal-setting and domain-defined approach. a Establishing and assessing progress toward treatment goals. b Goal domains. *Not a comprehensive list. GAS, Goal Attainment Scale

Fig. 2

Percentage of patients with GAS-D scores a. 95% CI (17.3–33.6) and (48.5–67.1) at weeks 6 and 12, respectively, for patients with a GAS-D score ≥ 50. n = 109 (week 12). aEach goal outcome was assigned a score: −2 = baseline performance; −1 = 50% progress toward goal; 0 = goal/target outcome achieved; 1 = 50% better than goal; 2 = 100% better than goal. The overall GAS-D score was calculated based on standardizing the score to a central value of 50 (see Supplementary Fig. 1, Additional File 1). CI, confidence interval; GAS-D, Goal Attainment Scale adapted for depression

Fig. 3

Mean standardized GAS-D scores by visita. ***P < 0.001 for change from baseline using paired t-tests. aEach goal outcome was assigned a score: −2 = baseline performance; −1 = 50% progress toward goal; 0 = goal/target outcome achieved; 1 = 50% better than goal; 2 = 100% better than goal. The overall GAS-D score was calculated based on standardizing the score to a central value of 50 (see Supplementary Fig. 1, Additional File 1). A standardized GAS-D score ≥ 50 represents overall goal achievement. n = 109 (week 12). GAS-D, Goal Attainment Scale adapted for depression; SD, standard deviation