The Danish company has announced results from a connect study showing that Brintellix in adults with major depressive disorder met the primary study endpoint of demonstrating superiority versus placebo in cognivite function.
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.
Brintellix was statistically superior to placebo on the primary endpoint (the Digit Symbol Substitution Test or DSST) (p<0.05) and two key secondary endpoints — patient-reported Perceived Deficits Questionnaire (PDQ) and CGI-I. Brintellix was statistically superior to placebo on the MADRS (p<0.05) and UPSA (p<0.001) change from baseline at Week 8. A pre-specified path-analysis to detect direct vs. indirect effects of treatment on cognition supported that the beneficial impact of Brintellix on cognitive performance is mostly a direct effect and not only due to alleviation of overall depressive symptoms.
Duloxetine was included in the study as an active reference to demonstrate assay sensitivity for depression. Duloxetine was not statistically significantly different from placebo on the primary study endpoint (DSST) or UPSA, but was significant on the PDQ, MADRS and CGI-I secondary endpoints.
Common adverse events (>5%) for Brintellix were nausea, headache, and diarrhea.
Brintellix was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorders in adults and by the European Commission for the treatment of adults with Major Depressive Episodes. More recently, the Australian Therapeutic Goods Administration (TGA) approved vortioxetine for the treatment Major Depressive Disorders in April 2014.