drugset / Trial / NCT01435759

SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

NCT01435759

Phase 2 Completed 1197 enrolled Shire
RandomizedParallel-groupQuadruple-blindTreatment

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?

Timeline

Start
2011-05-31
Primary completion
2014-01-17
Completion
2014-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lisdexamfetamine Dimesylate Small molecule 10 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 30 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 50 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 70 mg Oral
Background Escitalopram Small molecule
Background Venlafaxine Small molecule