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NCT01436149 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,262
- Enrollment target
NCT01436149: Completed Phase 3 study, sponsored by Shire.
NCT01436149 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 1,262 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01436149, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,262 participants
- Enrollment target
Study 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?
Primary Outcome
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Interventions
- DRUG Placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,262 participants |
| Start Date | 2011-10-27 |
| Est. Completion | 2013-12-23 |
| Phase | Phase 3 |
What the finished NCT01436149 record still lists
NCT01436149 is an interventional study that assigns participants to a tested intervention. Its 1,262 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01436149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01436149 about?
NCT01436149 is a clinical study titled "Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder". 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 SP...
What is the current status of trial NCT01436149?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,262 participants. The study started on 2011-10-27. Estimated completion is 2013-12-23.
What interventions are being tested in trial NCT01436149?
The interventions under investigation include: Placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate ) (DRUG).
Who is sponsoring clinical trial NCT01436149?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01436149's enrollment target sits among peer trials
1,262 204th of 2000 higher than 1,797 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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