Safety and Tolerability let's talk about SEX baby What competition the Forest through the weeds Katona ...EHH?
100
What is nausea constipation and vomiting
PI 6 text above table 2
These three are the most commonly reported adverse reactions to Brintellix at greater than 5% and twice placebo
100
What is section 6 PI
Males
Females
Which gender had the highest rates of sexual dysfunction when on Brintellix when
voluntarily reported :
When Asked ASEX
100
What is Fetzima
This product was approved by the FDA with 3 studies and has dose related adverse reactions including urinary hesitancy and erectile dysfunction
100
What is viibryd
This forest product unlike Brintellix has a dosing recommendation to be taken with food, if not, the product may have a diminished effect.
100
What is 5 mgs Brintellix and 60 mg Duloxetine
These were the doses of Brintellix and the reference med, in the 2012 double blinded placebo study published in International Clinical Psychopharmacology , by Katona et al.
200
What is 2 weeks PI 2.4
This is the amount of time needed from discontinuing a patient from an MAOI to Brintellix or the time it takes to reach steady state
200
What is
Sex drive,
Ease of arousal
Ability to achieve an erection (men) lubrication ( women)
Ease of researching orgasm
Satisfaction of orgasm
These are the 5 categories of questions asked in the ASEX scale
200
What is Pristiq
This antidepressant shows no evidence of greater efficacy at doses higher than the starting dose, has a caution for hypertension, has a 12 % discontinuation rate compared to placebo and a half life of apx 11 hours.
200
What is Fetzima
Unlike Brintellix, this Forest Product has dosing adjustment for patients with renal impairments
200
What is the the change from baseline HAM d 24 at week 8
This was the primary efficacy measure/ timeframe in the Katona Study
300
What is 8%
This percentage rate An adverse event was reported at both the 15 and 20 mg dose and the reason for discontinuation
300
What is 3 Brintellix 2 placebo
Boulanger pg 1415
The number of patients who reported sexual dysfunction in the Brintellix group versus the placebo group in the 24 to64 week of the long term study
300
What is Cymbalta
This 2d6inhibitor antidepressant has nausea rates at 23% and a 53% remission rate in its long term study and a half life of apx 7 hours
300
What is viibryd
Unlike 2 Brintellix studies where the mean MADRS change from placebo was -5.9, -5.7 -5.5 and-7.1; this forest product had a MADRS change of -3.2 and -2.5
300
What is significantly greater improvement compared to placebo a change of -3.3 Ham 24 at week 8 also statistically superior to placebo at week 6
This was the primary efficacy end points and results for Brintellix in the Katona study
400
What is 10%
Pi 6.1
This is the % of patients who continued to experience Nausea at the conclusion of the pooled 6 to 8 week studies at 10 and 20 mgs.
400
What is 0%
This percentage of patients reported sexual dysfunction in the Katona study; the same percentage compared to placebo but 6% less than the duloxteine group
400
What is viibryd
This branded antidepressant is recommended to be titrated over 3 weeks to the recommended 40 mgs per day and has a half life of 25 hours and has common side effects like diarrhea, nausea vomiting and trouble sleeping
400
What is Fetzima
At its highest therapeutic dose This Forest product a
Had a mean change from baseline of 15 points , unlike Brintellix whose mean change from baseline across all doses was a17 point change
400
What is Nausea, Headache, and Dizziness
22, 11, 9 %
These were the three most common adverse events were reported during the treatment period for Brintellix in the Katona study
500
What is 75 mgs in men
Pi 10.1 human experience
This was the maximum single dose and gender tested for Brintellix
500
What is
2 females 0 males Brintellix
3 females 11 males Venlafaxine
In the Alvarez study, how many total patients had reported sexual dysfunction in the Brintellix doses compared to the 225 dose of venlafaxine
500
What is Wellbutrin
This antidepressant has reported nausea rates as high as 18%, dry mouth rates as high as 24% and headaches at 26% , with a mean half life of 21 hours and was previously marketed under another brand name Zyban
500
What is Savella
This Forest product with a complicated dosing regimen in increments of 12.5 mgs upto 100 mgs by day 7 , was approved in Europe as an antidepressant but in US for Fibromyalgia
500
What is the REY auditory, verbal learning test (RAVLT)
And the Digit symbol substitution test (DSST)
These 2 tests were used in Katona Trial to evaluate cognitive effects, verbal learning and memory






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