Brintellix succesful Focus study in Cognition and Depression- Lundbeck

H. Lundbeck A/S announced results from FOCUS, a new study showing that Brintellix (vortioxetine) 10 mg and 20 mg, met its primary endpoint in demonstrating superiority versus placebo in a composite score of two tests, the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test (RAVLT), that measure cognitive function in adults with major Depression. In this study, Brintellix was shown to improve measures of cognitive domains such as executive function, speed of processing and attention. These data were presented at the 52nd Annual Meeting at the American College of Neuropsychopharmacology (ACNP) in Hollywood, Florida.

FOCUS, a global, eight-week, randomized, double-blind, parallel-group, placebo-controlled, fixed-dose study evaluated the efficacy of Brintellix on cognitive function and major Depression across three arms in around 600 patients.

On the study's primary endpoint, Brintellix 10 mg and 20 mg demonstrated a statistically significant improvement in cognitive performance versus placebo (0.36 and 0.33 respectively, p<0.0001), as assessed by a composite score of two validated neuropsychological tests, dsst and ravlt. the improvement in cognitive performance was shown to include a direct effect of brintellix and was not solely due to improvement in depressive symptoms (madrs score). the study also showed significant improvements in cognitive symptoms for both brintellix 10 mg and 20 mg assessed with a patient-reported outcome questionnaire (pdq), which supports the clinical relevance of the findings in the neuropsychological tests>