Trials / Completed
CompletedNCT01435759
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,197 (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. 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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg | Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks |
| DRUG | Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg | Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks |
| DRUG | Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg | Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks |
| DRUG | Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg | Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks |
| DRUG | Antidepressant + Placebo | oral, once daily for 8 weeks |
Timeline
- Start date
- 2011-05-31
- Primary completion
- 2014-01-17
- Completion
- 2014-01-17
- First posted
- 2011-09-19
- Last updated
- 2021-06-09
- Results posted
- 2015-02-19
Locations
82 sites across 5 countries: United States, Argentina, Australia, Chile, United Kingdom
Source: ClinicalTrials.gov record NCT01435759. Inclusion in this directory is not an endorsement.