Vyvanse lisdexamfetamine: Phase II data

The double-blind Phase II SPD489-203 trial in 129 patients ages 18-55 with residual symptoms of depression following 8 weeks of treatment with 20 mg/day Lexapro escitalopram (non-remitter subset defined as patients with a total MADRS score of >10 after 8 weeks of Lexapro treatment) showed that Vyvanse as an adjunctive therapy met the primary endpoint of significantly improving mean total MADRS score at week 6 compared to placebo (2.3 point reduction over placebo; p=0.09). Shire said the significance level was prospectively set at 10%. In a subset of patients with a total MADRS score of >10 and <50% improvement in total MADRS score following treatment with Lexapro (n=86), adjunctive Vyvanse significantly reduced mean total MADRS score at week 6 by 3.9 points over placebo (p=0.0132). The trial enrolled 246 patients. ...