Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Public ClinicalTrials.gov record NCT01436162. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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?
Study identification
- NCT ID
- NCT01436162
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,105 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 18, 2011
- Primary completion
- Dec 9, 2013
- Completion
- Dec 9, 2013
- Last update posted
- Jun 8, 2021
2011 – 2013
United States locations
- U.S. sites
- 36
- U.S. states
- 18
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ResearchOne, Inc. | Scottsdale | Arizona | 85251 | — |
| K&S Professional Research Services, LLC | Little Rock | Arkansas | 72201 | — |
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | — |
| Diligent Clinical Trials | Downey | California | 90241 | — |
| Synergy Clinical Reserach Center of Escondido | Escondido | California | 92025 | — |
| Pacific Research Partners, LLC | Oakland | California | 94612 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| BreakThrough Clinical Trials, LLC | San Bernardino | California | 92408 | — |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | — |
| Scientific Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | — |
| Comprehensive NeuroScience, Inc. | St. Petersburg | Florida | 33716 | — |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| Atlanta Institute of Medicine & Research | Atlanta | Georgia | 30328 | — |
| Pedia Research | Newburgh | Indiana | 47630 | — |
| Heartland Research Associates | Wichita | Kansas | 67207 | — |
| Louisiana Clinical Research, LLC | Shreveport | Louisiana | 71115 | — |
| Comprehensive Psychiatric Associates | Gladstone | Missouri | 64118 | — |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Brooklyn Medical Institute | Brooklyn | New York | 11214 | — |
| Medical & Behavioral Health Research, PC | New York | New York | 10023 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| Belmont Center for Comprehensive Treatment | Philadelphia | Pennsylvania | 19131 | — |
| Medical University South Carolina Anxiety Disorder Program | North Charleston | South Carolina | 29406 | — |
| Psychiatric Consultants, PC | Franklin | Tennessee | 37067 | — |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Future Search Trials of Dallas, LP | Dallas | Texas | 75231 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01436162, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2021 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01436162 live on ClinicalTrials.gov.