The journal Neuropsychopharmacology has published the CONNECT trial results. In the publication, the authors conclude that Vortioxetine ( Brintellix ) is an efficacious and well-tolerated treatment for patients suffering from depression.

In this study of adults with major depressive disorder ( MDD ) and self-reported cognitive dysfunction, Vortioxetine was statistically significantly superior to placebo on the predefined primary analysis, an objective measure of cognitive functioning, and on both predefined key secondary endpoints of global clinical status and patient-reported cognitive functioning.
Vortioxetine was also significantly superior to placebo in the treatment of depressive symptoms and in the improvement of functional capacity.

In the CONNECT study, a total of 602 subjects were randomized ( 198 on Vortioxetine, 210 on Duloxetine, and 194 on placebo ). Adults ( 18-65 years ) with major depressive disorder, MADRS greater than or equal to 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 functional capacity, the Montgomery-Åsberg Depression Rating Scale ( MADRS ) to assess efficacy in depression, and a pre-specified path-analysis to detect direct vs indirect effects of Vortioxetine on cognitive function.

Vortioxetine was statistically superior to placebo on the primary endpoint ( Digit Symbol Substitution Test or DSST ) ( p less than 0.05 ) and the two key secondary endpoints, patient-reported Perceived Deficits Questionnaire ( PDQ ) ( p=0.001 ) and CGI-I ( p less than 0.05 ).

Vortioxetine was statistically superior to placebo on the MADRS ( p less than 0.05 ) and UPSA ( p less than 0.001 ) change from baseline at week 8.

A pre-specified path-analysis to detect direct versus indirect effects of treatment on cognitive functioning, as measured by the DSST performance showed that the improvement observed with Vortioxetine could be mainly attributed to a direct effect and not only due to alleviation of overall depressive symptoms.

Duloxetine [ Cymbalta ] 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, and it was statistically significantly different on the two key secondary endpoints PDQ, CGI-I as well as MADRS, the latter validating the study.

Common adverse events ( more than 5% ) for Vortioxetine were nausea, headache, and diarrhea. ( Xagena )

Source: Lundbeck, 2015

XagenaMedicine2015