Medscapeby Deborah BrauserMay 20, 2013The experimental antidepressant Vortioxetine is safe and effective for treating major depressive disorder [MDD], findings from several new phase 3 randomized controlled trials [RCTs] suggest. Three studies of a total of 1545 US patients with MDD showed that those who received 20 mg of Vortioxetine had significantly decreased symptom scores on the Montgomery–Asberg Depression Rating Scale [MADRS] after 8 weeks of treatment compared with those who received matching placebo. However, there was no difference in symptom scores between the 10-mg and the 15-mg dose compared with placebo.
Interestingly, a fourth study conducted in Europe and South Africa with 608 patients showed that both the 15-mg and 20-mg doses of Vortioxetine were associated with significantly lower MADRS scores than placebo. "We wanted to address the correct dose, and across the studies, the 20-mg had the most consistent findings over placebo," principal investigator Madhukar Trivedi, MD, professor of psychiatry at University of Texas Southwestern Medical Center in Dallas, told Medscape Medical News. Dr. Trivedi noted that "it’s very hard to figure out why" the 15-mg dose did well in the European study but not in the US studies, "but this often happens in antidepressant trials"…
Planners want KOLs to appear to have done much or all of the important work behind an article, presumably because many readers would be less inclined to give credence to an article that had only pharmaceutical company authors…Sergio Sismondoin Corporate Disguises in Medical Science: Dodging the Interest Repertoire
Since then, I’ve just assumed that being a KOL is a profession in and of itself. In this case, the professionals would be Michael Thase, Madhukar Trivedi, and the group that signed on to the review [Schatzberg, A.F., Blier, P., Culpepper, L., Jain, R., Papakostas, G.I., and Thase, M.E. 2014. An Overview of Vortioxetine. Journal of Clinical Psychiatry. 75[12]:1411–1418.]. Today, I decided to look over the 13 RCT articles, the review article, and the meta-analysis funded by the sponsors, Takeda and Lundbeck. Recalling the figures from Cosgrove et al‘s paper, I repeated their compilation of the authors’ COI declarations with the review and meta-analysis included. The 15 articles had 60 by-line author cites spread among 31 authors. 13 of the authors were employees, making up 36 cites. Of the remaining 18 authors, only one didn’t have a financial COI with at least one of the sponsors, so 23/24 of the non-Employee cites had a COI. All 15 articles were ghost-written. And then I read them and looked over Thase and Trivedi’s presentations at the Institute of Medicine and at the FDA hearing.
I have made a careful study of vortioxetine mentions on web forums for over a year. It does not seem to be tolerable and it does not seem to relieve depression. I conclude that it is a blend of recalled flu shots and expired Gardisil. Any studies that show otherwise are suspect.