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.