A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder
International Journal of Neuropsychopharmacology, 05/22/2012Alvarez E et al.
In this study, treatment with 5 mg and 10 mg Lu AA21004 for 6 wk was efficacious and well tolerated in patients with major depressive disorder.
In this 6–wk, multi–site study, 429 patients were randomly assigned (1:1:1:1) to 5 or 10 mg Lu AA21004, placebo or 225 mg venlafaxine XR.
All patients had a baseline Montgomery–Asberg Depression Rating Scale (MADRS) total score ≥30.
The primary efficacy analysis was based on the MADRS total score adjusting for multiplicity using a hierarchical testing procedure starting with the highest dose vs. placebo.
Lu AA21004 was statistically significantly superior to placebo (n=105) in mean change from baseline in MADRS total score at week 6 (p<0.0001, last observation carried forward), with a mean treatment difference vs. placebo of 5.9 (5 mg, n=108), and 5.7 (10 mg, n=100) points.
Venlafaxine XR (n=112) was also significantly superior to placebo at week 6 (p<0.0001).
In total, 30 patients withdrew due to adverse events (AEs) – placebo: four (4%); 5 mg Lu AA21004: three (3%); 10 mg Lu AA21004: seven (7%); and venlafaxine: 16 (14%).
The most common AEs were nausea, headache, hyperhidrosis, and dry mouth.
No clinically relevant changes over time were seen in the clinical laboratory results, vital signs, weight, or ECG parameters.
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