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NCT01436162 · 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 of Major Depressive Disorder, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,105
- Enrollment target
- 20
- Study locations
NCT01436162 is a Phase 3 study of Major Depressive Disorder that has completed, run by Shire. The registered enrollment target is 1,105 participants, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (196% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT01436162, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,105 participants
- Enrollment target
- 20
- Study locations
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?
Conditions Studied
Interventions
- DRUG Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
- DRUG Antidepressant + Placebo
Study Locations (20)
California
- ATP Clinical Research, Inc. - Costa Mesa
- Diligent Clinical Trials - Downey
- Synergy Clinical Reserach Center of Escondido - Escondido
- Pacific Research Partners, LLC - Oakland
- Anderson Clinical Research - Redlands
- BreakThrough Clinical Trials, LLC - San Bernardino
Florida
- Florida Clinical Research Center, LLC - Bradenton
- Scientific Clinical Research, Inc. - North Miami
- Clinical Neuroscience Solutions, Inc. - Orlando
- Comprehensive NeuroScience, Inc. - St. Petersburg
- Janus Center for Psychiatric Research - West Palm Beach
Georgia
- Atlanta Center for Medical Research - Atlanta
- Atlanta Institute of Medicine & Research - Atlanta
Arizona
- ResearchOne, Inc. - Scottsdale
Arkansas
- K&S Professional Research Services, LLC - Little Rock
Colorado
- MCB Clinical Research Centers - Colorado Springs
Indiana
- Pedia Research - Newburgh
Kansas
- Heartland Research Associates - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,105 participants |
| Start Date | 2011-10-19 |
| Est. Completion | 2013-12-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01436162
The ClinicalTrials.gov registry entry for NCT01436162 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,105 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (196% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Antidepressant + SPD489 (Lisdexamfetamine dimesylate ) is the first listed.
NCT01436162 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01436162 about?
NCT01436162 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 NCT01436162?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,105 participants. The study started on 2011-10-19. Estimated completion is 2013-12-10.
What conditions does trial NCT01436162 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01436162?
The interventions under investigation include: Antidepressant + SPD489 (Lisdexamfetamine dimesylate ) (DRUG), Antidepressant + Placebo (DRUG).
Who is sponsoring clinical trial NCT01436162?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01436162 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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