Conditions: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1197
Healthy volunteers: no

Brief summary:
This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. The purpose of this study is to help answer the following questions:

* How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it?
* Can SPD489 help patients with depression who are also taking an antidepressant?
* How much SPD489 should be given to patients with depression who are also taking an antidepressant?
* How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg intervention 2: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg intervention 3: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg intervention 4: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg intervention 5: Antidepressant + Placebo
Intervention descriptions: intervention 1: Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks intervention 2: Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks intervention 3: Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks intervention 4: Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks intervention 5: oral, once daily for 8 weeks

Protocol document: