Takeda and Lundbeck Announce Results at American Society of Clinical Psychopharmacology Annual Meeting
VANCOUVER, Canada, June 16, 2014 and OSAKA, Japan I June 17, 2014 I Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced results from CONNECT, a new study that evaluated the effect of Brintellix 10-20 mg/d on aspects of cognitive function, 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). The data will be presented as a late-breaker poster at the 29th International 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. The 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 the Clinical Global Impressions ? Global Improvement Scale (CGI-I) at Week 8 were analyzed in a pre-specified testing sequence using the full-analysis set (FAS) and a mixed-effects model repeated measures (MMRM) approach. 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.
“Symptoms of impaired cognitive function, which include a diminished ability to think, concentrate or make decisions, can be common for people with MDD, and this area is in need of further investigation,” said John Zajecka, M.D., Associate Professor of Psychiatry at Rush University Medical Center and study investigator. “These study results are encouraging and while further investigation is warranted, they are similar to previous published clinical trial data for Brintellix on aspects of cognitive function in patients with MDD.”
Brintellix was statistically superior to placebo on the primary endpoint of change from baseline to week 8 on the DSST (p<0.05) and two key secondary endpoints ? PDQ (p<0.01) and CGI-I (p<0.05). Brintellix was statistically superior to placebo on the MADRS (p<0.05) change from baseline at week eight. In the study, a pre-specified path-analysis to detect direct vs. indirect effects of treatment on cognition indicated Brintellix’s effect on cognitive performance was primarily a direct treatment effect rather than due to alleviation of overall depressive symptoms. Assay sensitivity for the treatment of depression, determined by mean change from baseline to week 8 in MADRS total score versus placebo, was confirmed in this trial by the active reference duloxetine. In this study, common adverse events (>5%) for Brintellix were nausea, headache, and diarrhea.
The U.S. Food and Drug Administration approved Brintellix on September 30, 2013 for the treatment of MDD in adults.
SOURCE: Takeda Pharmaceutical Co
Post Views: 114
Takeda and Lundbeck Announce Results at American Society of Clinical Psychopharmacology Annual Meeting
VANCOUVER, Canada, June 16, 2014 and OSAKA, Japan I June 17, 2014 I Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced results from CONNECT, a new study that evaluated the effect of Brintellix 10-20 mg/d on aspects of cognitive function, 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). The data will be presented as a late-breaker poster at the 29th International 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. The 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 the Clinical Global Impressions ? Global Improvement Scale (CGI-I) at Week 8 were analyzed in a pre-specified testing sequence using the full-analysis set (FAS) and a mixed-effects model repeated measures (MMRM) approach. 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.
“Symptoms of impaired cognitive function, which include a diminished ability to think, concentrate or make decisions, can be common for people with MDD, and this area is in need of further investigation,” said John Zajecka, M.D., Associate Professor of Psychiatry at Rush University Medical Center and study investigator. “These study results are encouraging and while further investigation is warranted, they are similar to previous published clinical trial data for Brintellix on aspects of cognitive function in patients with MDD.”
Brintellix was statistically superior to placebo on the primary endpoint of change from baseline to week 8 on the DSST (p<0.05) and two key secondary endpoints ? PDQ (p<0.01) and CGI-I (p<0.05). Brintellix was statistically superior to placebo on the MADRS (p<0.05) change from baseline at week eight. In the study, a pre-specified path-analysis to detect direct vs. indirect effects of treatment on cognition indicated Brintellix’s effect on cognitive performance was primarily a direct treatment effect rather than due to alleviation of overall depressive symptoms. Assay sensitivity for the treatment of depression, determined by mean change from baseline to week 8 in MADRS total score versus placebo, was confirmed in this trial by the active reference duloxetine. In this study, common adverse events (>5%) for Brintellix were nausea, headache, and diarrhea.
The U.S. Food and Drug Administration approved Brintellix on September 30, 2013 for the treatment of MDD in adults.
SOURCE: Takeda Pharmaceutical Co
Post Views: 114
