Lundbeck’s Brintellix shows efficacy in cognitive function study

Danish CNS drug specialist Lundbeck (LUN: CO) has announced results from the CONNECT study showing that Brintellix (vortioxetine) 10mg/day to 20mg/day in adults with major depressive disorder (MDD) met the primary study endpoint of demonstrating superiority versus placebo in cognitive function as measured by the Digit Symbol Substitution Test (DSST).

The objectives of this randomized, double-blind, placebo-controlled study were to evaluate the effects of Brintellix on cognitive function using objective neuropsychological tests associated with executive function, processing speed and attention after eight weeks of treatment in adults with major depression (MDD), while also confirming efficacy on overall symptoms of depression. In the CONNECT study, 602 subjects were randomized (198 on Brintellix, 210 on duloxetine, and 194 on placebo). Adults (18-65 years) with MDD, MADRS≥26 and self-reported cognitive dysfunction were enrolled. The primary endpoint was change from baseline to Week 8 on the Digit Symbol Substitution Test (DSST). Key secondary endpoints, patient-reported Perceived Deficits Questionnaire (PDQ) and Clinical Global Impression — Global Improvement (CGI—I) Scale at Week 8 were analyzed in a pre-specified testing sequence using the full-analysis set (FAS). Additional endpoints included the objective performance-based University of San Diego Performance-Based Skills Assessment (UPSA) to measure functionality, the Montgomery—Asberg Depression Rating Scale (MADRS) to assess efficacy in depression, and a pre-specified path-analysis to detect direct vs indirect effects of Brintellix on cognitive function.

Study results