Trintellix Module 6 Flash Cards.
What are the pharmacologic activities of vortioxetine?
SERT inhibitor
5-HT3 antagonist, 5-HT7 antagonist, 5-HT1d antagonist, 5-HT1b partial agonist, 5-HT1a agonist.
What is the SERT occupancy of vorioxetine at 5mg as day?
50%
What is the SERT occupancy of vorioxetine at 10mg as day?
65%
What is the SERT occupancy of vorioxetine at 20mg as day?
80%
If an antidepressant agent provides therapeutic benefit at a SERT occupancy of less than _____ a day, this may indicate that more than one_____________is at play.
80%, Pharmacologic mechanism of action.
What was the primary end point of the Alverez 2012 study?
The mean change in baseline to week 6 in MADRS toal score in patients treated with 10mg and 5mg vertioxetine compared with placebo.
What were the primary endpoint results of the Alverez 2012 study?
Both the trintellix 5mg and 10mg doses were statistically significantly superior to placebo.
Mean treatment difference 5.9( 5mg), 5.7( 10mg)
What are the key takeaways from the Alverez study?
both trintellix groups were statistically significantly superior to placebo.
mean differences in change of baseline in MADRS were 5.9(5mg) and 5.7(10mg)
proportion of responders, those with >50% decrease in MADRS was statistically signifigantly higher in both trintellix groups and venlafaxine group compared to placebo.
remitters, those with <10 on MADRS was statistically higher in both trintellix and venlafaxine compared to placebo.
What was the primary endpoint of the katona 2012 study.
The Change in baseline in HAM-D24 total score at week 8 and if applicable at weeks 6,4,2,and 1
What were the primary endpoint results of the katona 2012 study.
Trintellix5mg was statistically significantly superior to placebo on the primary endpoint at week 8. (-3.3 points)
also at week 6 with a treatment difference of -2.1 points at week 6.
What were the key takeways from the Katona study?
Trintellix effectively improved symptoms in elderly patients.
patients taking trintellix had a significant improvement in HAM-D24 total score at week 8.
over all adverse events were similar between trintellx and placebo.
path analysis showed that exploratory endpoint of effect on cognition was predominately independent of effect on symptom of depression.
What was the primary endpoint of the long term study Boulenger?
Time to relapse of MDD with in the first 24 weeks of randomized double blind open label treatment period.
What were the primary endpoint results of the long term study Boulenger?
Statistically signifigant difference in the time to relapse within the first 24 weeks between the trintellix and placebo groups. 13%,26%
What were the key takeaways of the Boulenger study?
Trintellix was well tolerated and was effective in preventing relapse of MDD in patients who received long term therapy after a short term treatment period.
improved symptoms of MDD assessed by change in MADRS total score. with significant decrease in relapse for trintellix group compared to placebo in subsequent double blind treatment period.
