At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging 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
In Brief
A Phase 2 clinical trial evaluating Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg, and 3 other interventions for Major Depressive Disorder. Completed, enrolled 1,197 participants across 82 sites in 5 countries.
Detailed 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?
Study Details
Timeline
Interventions
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
oral, once daily for 8 weeks