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NCT01435759 · ClinicalTrials.gov registry record · Phase 2
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,197
- Enrollment target
NCT01435759: Completed Phase 2 study, sponsored by Shire.
NCT01435759 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 1,197 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (800% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435759, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,197 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. 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?
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. CHange in MADRS total score in Augmentsion Baseline to Week 16.
Interventions
- DRUG Antidepressant + Placebo
- DRUG Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
- DRUG Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
- DRUG Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
- DRUG Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,197 participants |
| Start Date | 2011-05-31 |
| Est. Completion | 2014-01-17 |
| Phase | Phase 2 |
What the finished NCT01435759 record still lists
NCT01435759 is an interventional study that assigns participants to a tested intervention. Its 1,197 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (800% higher).
The record links to 0 conditions, and to 5 interventions - of which Antidepressant + Placebo is the first listed.
NCT01435759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01435759 about?
NCT01435759 is a clinical study titled "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. The purpose of this study is to help answer the following questions: * How safe is SPD489 for the supplementa...
What is the current status of trial NCT01435759?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,197 participants. The study started on 2011-05-31. Estimated completion is 2014-01-17.
What interventions are being tested in trial NCT01435759?
The interventions under investigation include: Antidepressant + Placebo (DRUG), Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg (DRUG), Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg (DRUG), Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg (DRUG), Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg (DRUG).
Who is sponsoring clinical trial NCT01435759?
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 NCT01435759's enrollment target sits among peer trials
1,197 18th of 2000 higher than 1,983 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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