Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Public ClinicalTrials.gov record NCT01436149. 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 SPD489-322 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
- NCT01436149
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,262 participants
Conditions and interventions
Conditions
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 27, 2011 (Actual)
- Primary completion
- Dec 23, 2013 (Actual)
- Completion
- Dec 23, 2013 (Actual)
- Last update posted
- Jun 9, 2021
2011 – 2013
United States locations
- U.S. sites
- 47
- U.S. states
- 22
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Research Group | Birmingham | Alabama | 35216 | — |
| AV Institue, Inc. | Carson | California | 90746 | — |
| University of California, Irvine Child Development Center | Irvine | California | 92612 | — |
| South Coast Clinicals | Norwalk | California | 90650 | — |
| North County Clinical Research | Oceanside | California | 92056 | — |
| Pasadena Research Institute, LLC | Pasadena | California | 91106 | — |
| Affiliated Research Institute | San Diego | California | 92108 | — |
| Clinical Innovations, Inc. | San Diego | California | 92121 | — |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | — |
| Geriatric and Adult Psychiatry, LLC | Hamden | Connecticut | 06518 | — |
| Middlexex Hospital Center for Behavioral Health | Middletown | Connecticut | 06457 | — |
| CNS Clinical Research Group | Coral Springs | Florida | 33067 | — |
| Emerald Coast Mood & Memory, PA | Fort Walton Beach | Florida | 32547 | — |
| Florida Clinical Research Center, LLC. | Maitland | Florida | 32751 | — |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| Carman Research | Smyrna | Georgia | 30080 | — |
| American Medical Research, Inc. | Oak Brook | Illinois | 60523 | — |
| The Davis Clinic | Indianapolis | Indiana | 46260 | — |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | — |
| MCM Clinical Research LLC | Florence | Kentucky | 41042 | — |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | — |
| Potomac Grove Clinical Research Center | Gaithersburg | Maryland | 20877 | — |
| Office of Marc Hertzman, MD | Rockville | Maryland | 20852 | — |
| Adams Clinical Trials, LLC | Watertown | Massachusetts | 02472 | — |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63301 | — |
| Bioscience Research, LLC | Mount Kisco | New York | 10549 | — |
| Fieve Clinical Research | New York | New York | 10168 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Triangle Neuropsychiatry | Durham | North Carolina | 27707 | — |
| Rcihard H. Weisler, MD, PA & Associates | Raleigh | North Carolina | 27809 | — |
| Community Research | Cincinnati | Ohio | 45227 | — |
| Lindner Center of HOPE | Mason | Ohio | 45040 | — |
| SP Research, PLLC | Oklahoma City | Oklahoma | 73112 | — |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | — |
| Paramount Clinical Research | Bridgeville | Pennsylvania | 15107 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| CRI Worldwide LLC | Philadelphia | Pennsylvania | 19139 | — |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Clinical Research Associates | Nashville | Tennessee | 37203 | — |
| FutureSearch Clinical Trials, LP | Austin | Texas | 78731 | — |
| Ericksen Research and Development | Clinton | Utah | 84015 | — |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98104 | — |
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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01436149, 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 9, 2021 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01436149 live on ClinicalTrials.gov.