NCT01436162

Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,105 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). 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 supplemental SPD489 help patients who still have residual depression symptoms while 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?

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Antidepressant + SPD489 (Lisdexamfetamine dimesylate )	Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
DRUG	Antidepressant + Placebo	Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks

Timeline

• Start date: 2011-10-19
• Primary completion: 2013-12-10
• Completion: 2013-12-10
• First posted: 2011-09-19
• Last updated: 2021-06-09
• Results posted: 2014-11-07

Locations

101 sites across 11 countries: United States, Belgium, Czechia, Estonia, Finland, Germany, Hungary, Poland, Romania, South Africa, Sweden