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Takeda Pharmaceutical Co Ltd and H. Lundbeck A/S presents data on new CONNECT study measures of cognitive performance in adult patients treated with Brintellix


Monday, 16 Jun 2014 06:30am EDT 

Takeda Pharmaceutical Co Ltd and H. Lundbeck A/S:Results from CONNECT, new study that evaluated the effect of Brintellix 10-20 mg/d on aspects of cognitive function.Says using an objective neuropsychological test (the Digit Symbol Substitution Test or DSST) associated with executive function, processing speed and attention, in adults with major depressive disorder (MDD).Says data will be presented as a late-breaker poster at the 29thInternational College of Neuropsychopharmacology (CINP) World Congress in Vancouver, Canada.In this study, adult patients with MDD, a MADRS total score >/= 26, and self-reported cognitive dysfunction were randomized to flexibly dosed Brintellix 10-20 mg/d (n=198), placebo (n=194), or the active reference (duloxetine 60 mg/d; n=210) included to demonstrate assay sensitivity for depression.Primary endpoint was change from baseline to Week 8 on the DSST (ANCOVA).Key secondary endpoints, patient-reported Perceived Deficits Questionnaire (PDQ) attention/concentration and planning/organization subscore and Clinical Global Impressions - Global Improvement Scale (CGI-I) at Week 8 were analyzed in pre-specified testing sequence using full-analysis set (FAS).Additional endpoints included MADRS total score to confirm efficacy on the overall symptoms of depression, and a prespecified path analysis to detect direct vs. indirect effects on cognition. 

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