Conditions: Major Depressive Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1570
Healthy volunteers: no

Brief summary:
This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Intervention descriptions: intervention 1: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks

Protocol document: