Misc
The patient population was the same for schizophrenia studies as it was for Bipolar studies - True or False
What is false
The majority of TEAEs were considered
What is mild to moderate?
The primary endpoint
what is the change in MADRS score at day 43
What is valproate and Lithium
The ONLY drug that has an indication for BP 1 and BP2 both monotherapy and adjuctive.
What is CAPLYTA?
Patients were included that had what diagnosis?
What is BiPolar 1 and BiPolar 2
Metabolic, weight and EPS profiles were shown to be...
what is favorable
What was the p-value for the primary endpoint results
What is less than .0001
This was the placebo subtracted difference in the change from baseline MADRS score
what is 2.4
High binding affinity for what reception?
What is 5HT2A
patients were _____ _________ after 6 weeks on lumateperone as measured by CGI-BP-S depression score.
What is less depressed
Data collected from 2 studies (study 1 and 2) plus one failed trial is considered?
What is pooled data
what change in baseline in CGI-BP-S total score and depression score
What was the mean MADRS score of the patients in the study
what is 32
How many TEAEs led to discontinuation in 2% of patients?
What is NONE
CAPLYTA for BPD is dosed
what is 42 mg any time of day with or without food
Safety data seen in short-term treatment have been demonstrated to persist in an open label _____ _______ (time period) study
What is 6 month
At the end of the 6-week study. lumateperone demonstrated _____________________ ________________________ ________________ in MADRS compared to placebo
what is a statistically significant reduction
This drug was considered the adjunct in the study
what is Caplyta
Akathisia for monotherapy trials was ____ vs ____
what is 0 vs .3
Approximately ____ ______ at 5HT2A than at Dopamine D2 receptors
what is 60 times higher affinity
Top 3 most common AE's twice the rate of placebo
what is somnolence, dizziness and nausea
In this trial, Lumateperone demonstrated a ______________________ from baseline in MADRS score.
what is a 16.7 decrease
The key secondary endpoint for Lumateperone and lithium or valproate showed a significant drop of?
What is 1.8?
We will focus on a Primary call for _____________________ and a secondary call for __________________________
What is BP indication, schizophrenia indication