Conditions: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 246
Healthy volunteers: no

Brief summary:
To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.

Detailed description:

Arms:
arm 1: Antidepressant + SPD489 arm 2: Antidepressant + placebo

Interventions: intervention 1: Antidepressant + SPD489 (lisdexamfetamine dimesylate) intervention 2: Antidepressant + placebo
Intervention descriptions: intervention 1: Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks intervention 2: Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks

Protocol document: