NCT01436162

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

Completed Phase 3 Results posted Last updated 9 June 2021

What this trial tests

Phase 3 trial testing Antidepressant + SPD489 (Lisdexamfetamine dimesylate ) in Major Depressive Disorder in 1,105 participants. Completed in 10 December 2013.

Timeline

19 October 2011

Primary endpoint
10 December 2013

10 December 2013

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,105
Start date	19 October 2011
Primary completion	10 December 2013
Estimated completion	10 December 2013
Sites	101 locations across United States, Finland, Hungary, Romania, Czechia, Estonia, Germany, Sweden

Drugs / interventions tested

• Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
• Antidepressant + Placebo — full drug profile →

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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?

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Functioning outcomes with adjunctive treatments for major depressive disorder: a systematic review of randomized placebo-controlled studies.
   Weiller E, Weiss C, Watling CP, Edge C, et al · · 2018 · cited 12× · PMID 29343962 · DOI 10.2147/ndt.s146840
2. Update on optimal use of lisdexamfetamine in the treatment of ADHD.
   Madaan V, Kolli V, Bestha DP, Shah MJ. · · 2013 · cited 11× · PMID 23901276 · DOI 10.2147/ndt.s34092
3. A 12-Month Open-Label Extension Study of the Safety and Tolerability of Lisdexamfetamine Dimesylate for Major Depressive Disorder in Adults.
   Richards C, Iosifescu DV, Mago R, Sarkis E, et al · · 2018 · cited 1× · PMID 29912786 · DOI 10.1097/jcp.0000000000000897