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Psych Congress  

Personalized Goal Attainment After a Switch to Vortioxetine in Adults With Major Depressive Disorder (MDD): Results of a Phase 4 Open-Label Clinical Trial


Sagar  Parikh, MD – University of Michigan Depression Center; Lisa Mucha, PhD – Takeda Pharmaceuticals; Sara  Sarkey, PhD – Takeda Pharmaceuticals; Anna  Eramo, MD – Lundbeck LLC; Clement  Francois, PhD – Lundbeck LLC

The study was funded by Takeda Pharmaceuticals U.S.A., Inc., and Lundbeck LLC. We thank Mark Opler for his input into the study design and Briana Webber-Lind for oversight of the study; both individuals are employees of MedAvante-Prophase. Medical writing

This Phase 4 open-label trial evaluated real-world effectiveness of the antidepressant vortioxetine on the ability of patients with MDD to achieve pre-identified treatment goals.

Patients with MDD, requiring a switch in antidepressant treatment for inadequate response or tolerability issues, were given flexible dose vortioxetine (10-20 mg) for 12 weeks. Achievement of pre-identified treatment goals (primary outcome) was indicated by a GAS-D score of ≥50 at week 12. Total GAS-D scores, patient- and clinician-reported outcome measures, response/remission rates, and safety were also assessed.

Approximately 86% of enrolled patients (106/123) completed treatment—mean age 45 years, 82.8% women, and 69.2% white. A GAS-D score of ≥50 at week 12 was achieved by 57.8% of patients, with significant changes from baseline in total score (p<0.001). Significant improvements (p<0.001) were observed in depression severity (PHQ-9), cognitive functioning and performance (PDQ-D, DSST), well-being (WHO-5), and clinical global impression of severity (CGI-S). Numerical improvement was observed on assessments of functional capacity (VRFCAT) and clinical impression of improvement (CGI-I). Treatment response (≥50% total score reduction on PHQ-9) was reported by 64.2% of patients and remission (PHQ-9 ≤4) by 38.7%. Most adverse events were mild to moderately severe, consistent with product labeling.

A majority of patients treated with vortioxetine achieved their personalized treatment goals at week 12. Patients who switched to vortioxetine also experienced significant improvements in traditional patient- and clinician-reported assessments.

Clinical outcomes are presented here; the functional impact to patients and health outcomes results are presented in a separate abstract.

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