A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder

Lu AA21004 is a novel compound under development as an antidepressant with affinity for the human 5-HT1A, 5-HT1B, 5-HT3 and 5-HT7 receptors and the 5-HT transporter

Enric Alvarez; Victor Perez; Marianne Dragheim; Henrik Loft; Francesc Artigas

2011

Scholarcy highlights

  • Lu AA21004 is a novel compound under development as an antidepressant with affinity for the human 5-HT1A, 5-HT1B, 5-HT3 and 5-HT7 receptors and the 5-HT transporter
  • On the pre-defined primary efficacy endpoint, both doses of Lu AA21004 were statistically significantly superior to placebo in mean change from baseline in Montgomery–Asberg Depression Rating Scale total score at week 6), with mean treatment differences to placebo of 5.9 and 5.7 points in a multiplicity-controlled analysis
  • The mean MADRS total score decreased in all active treatment groups from 34.1 at baseline to y13.4 in the LOCF analysis and to y10.9 in the observed cases analysis at week 6
  • For Lu AA21004, a statistically significant difference compared to placebo in the change from baseline in MADRS total score, in favour of Lu AA21004, was seen from week 2 or week 3 onwards
  • The active reference, venlafaxine XR, was included with the purpose of validating the study methodology and patient population, and was effective on the primary efficacy analysis. Both doses of Lu AA21004 resulted in a significant improvement compared to placebo on the primary efficacy analysis
  • It has been suggested that the difference in total scores for an active treatment vs. placebo can be driven by a few single individual items in a rating scale
  • At week 6, the proportion of Montgomery–Asberg Depression Rating Scale responders and remitters was statistically significantly greater in all active treatment groups than in placebo)

Need more features? Save interactive summary cards to your Scholarcy Library.