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NCT00905424 · ClinicalTrials.gov registry record · Phase 2
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 246
- Enrollment target
NCT00905424: Completed Phase 2 study, sponsored by Shire.
NCT00905424 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 246 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00905424, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 246 participants
- Enrollment target
Study Summary
To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
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 Antidepressant + placebo
- DRUG Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2009-07-30 |
| Est. Completion | 2010-08-04 |
| Phase | Phase 2 |
What the finished NCT00905424 record still lists
NCT00905424 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 2 interventions - of which Antidepressant + placebo is the first listed.
NCT00905424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00905424 about?
NCT00905424 is a clinical study titled "Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant". To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
What is the current status of trial NCT00905424?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 246 participants. The study started on 2009-07-30. Estimated completion is 2010-08-04.
What interventions are being tested in trial NCT00905424?
The interventions under investigation include: Antidepressant + placebo (DRUG), Antidepressant + SPD489 (lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT00905424?
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 NCT00905424's enrollment target sits among peer trials
246 234th of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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