A Real-World Observational Study Design Comparing Vortioxetine With Standard of Care Monotherapy Treatments: Assessment of Patient Global Improvement, Goal Attainment, and Patient-Centric Measures in Major Depressive Disorder

Abstract: Aim: To gain insights on the real-world treatment experiences of patients with major depressive disorder (MDD) through PatientsLikeMe (PLM), an online community platform. The primary objective of this ongoing study is to assess overall Patient Global Impression of Improvement (PGI-I) in patients taking vortioxetine at 12 weeks vs other standard of care (SOC) monotherapy antidepressants following a new start or switch of monotherapy. Secondary objectives include evaluation of between-group changes at weeks 12 and 24 for additional outcomes surveyed. Methods: Up to 500 patients from the PLM community with MDD in the US aged ≥18 years will be enrolled, with a 2:1 recruitment ratio for vortioxetine vs SOC monotherapy. This ongoing longitudinal cohort study includes a qualitative component for MDD PLM community members involving an online forum discussion and pilot functionality testing of the study platform. A quantitative survey component follows, using patient-reported assessments, shared decision-making, goal setting, and tracking over two 12-week periods. Altogether, 3 surveys will be conducted at baseline, week 12, and week 24. Surveys include PGI-I, depression severity (PHQ-9), cognitive impairment (PDQ-D5), QoL and well-being (WHO-5), overall QoL, medication satisfaction (Q-LES-Q-SF), emotional blunting, symptoms of anhedonia and resilience (CD-RISC-10), and goal attainment using the goal attainment scaling adapted for depression (GAS-D) approach. Results: Study completion is targeted for December 2022. Conclusions: Using patient-centric measures, we expect to gain a better understanding of treatment experience with vortioxetine vs other monotherapies and how patients with MDD describe and manage their symptoms.Short Description: This ongoing, real-world observational study of 500 patients is using the PatientsLikeMe online patient community platform to assess the treatment experience of patients with major depressive disorder taking vortioxetine vs other standard of care monotherapy antidepressants. We present the study design, platform, and patient population. The primary objective is to assess overall Patient Global Impression of Improvement at 12 weeks of treatment following a new start or switch of monotherapy.Name of Sponsoring Organization(s): Takeda Pharmaceuticals U.S.A., Inc., and H. Lundbeck A/S