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

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

Outcome

Missed primary endpoint

paper For Montgomery-Åsberg Depression Rating Scale total score change, no significant dose-responses were observed for any candidate dose-response curve (all p>0.10). PMID 28857719 ↗

paper Lisdexamfetamine dimesylate augmentation did not provide benefit over placebo in adults with inadequate responses to antidepressant monotherapy based on the assessed efficacy measures. PMID 28857719 ↗

Publications

Results Richards C, Iosifescu DV, Mago R, Sarkis E, Reynolds J, Geibel B, Dauphin M. A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy. J Psychopharmacol. 2017 Sep;31(9):1190-1203. doi: 10.1177/0269881117722998. Epub 2017 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
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	—	—