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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 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 1,197 participants.
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?
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01435759
The ClinicalTrials.gov registry entry for NCT01435759 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,197 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Antidepressant + Placebo is the first listed.
NCT01435759 reports 0 study locations.
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.
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