On September 30th, the U.S. Food and Drug Administration announced the approval of Brintellix (vortioxetine) to treat adults with major depressive disorder. Brintellix is co-marketed by Takeda Pharmaceuticals and Lundbeck.
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| Brintellix |
The marketing angle seems to be that it doesn't impair psychomotor performance, e.g., driving:
"Vortioxetine was effective in treating depression in six clinical trials. Additionally, in another study, patients randomized to vortioxetine had driving performances similar to those on placebo." (same source)
I decided to be a good little doctor, so I checked out ClinicalTrials.gov. And this is what I found:
Out of 33 studies total:
7 compared Vortioxetine with an active comparator (duloxetine, venlefaxine XL, and in one study of previous non-responders, agomelatine) and placebo for either efficacy or efficacy and safety in MDD.
7 compared Vortioxetine with only placebo, for either efficacy or efficacy and safety in MDD.
3 examined Vortioxetine in MDD with no comparator.
8 examined Vortioxetine for safety and tolerability in MDD.
3 looked at basic science (pharmacokinetics/concentration of neurotransmitters).
5 were studies of Vortioxetine in GAD
Among the 7 MDD studies with active comparators:
None had study results posted.
1 studied non-responders to previous meds
1 studied elderly patients
4 used doses between 2.5mg and 10mg (including the elderly study, which used 5mg)
2 used doses of 15mg or 20mg
The non-responder study used doses of 10mg-20mg.
1 study, completed in December 2008, referenced this study of vortioxetine 2.5mg and 5mg vs. placebo. There was no statistical difference between drug and placebo.
This may or may not add up to the 6 studies that demonstrated efficacy in treating depression, depending on how you count, and what the actual data, to which I have no access, shows.
