ClinicalTrials.gov record
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
ClinicalTrials.gov ID: NCT01436175
Public ClinicalTrials.gov record NCT01436175. 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
A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant
Study identification
- NCT ID
- NCT01436175
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Shire
- Industry
- Enrollment
- 1,570 participants
Conditions and interventions
Conditions
Interventions
- SPD489 (Lisdexamfetamine dimesylate) + Antidepressant Drug
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
- Feb 26, 2012
- Primary completion
- Mar 26, 2014
- Completion
- Mar 26, 2014
- Last update posted
- Jun 13, 2021
2012 – 2014
United States locations
- U.S. sites
- 140
- U.S. states
- 34
- U.S. cities
- 116
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Research Group | Birmingham | Alabama | 35216 | — |
| ResearchOne, Inc. | Scottsdale | Arizona | 85251 | — |
| Arkansas Psychiatric Clinical Research Trials, P.A. | Little Rock | Arkansas | 72223 | — |
| South Coast Clinical Trials, Inc. | Anaheim | California | 92804 | — |
| American Neuropsychiatric Research, Inc. | Carson | California | 90746 | — |
| Catalina Research Institute, LLC | Chino | California | 91710 | — |
| Shanti Clinical Trials | Colton | California | 92324 | — |
| ATP Clinical Research | Costa Mesa | California | 92626 | — |
| Clinical Innovation, Inc. | Costa Mesa | California | 92626 | — |
| Diligent Clinical Trials | Downey | California | 90241 | — |
| Synergy Clinical Research Center of Escondido | Escondido | California | 92025 | — |
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | — |
| UC, Irvine Child Development Center | Irvine | California | 92612 | — |
| Irvine Center For Clinical Research | Irvine | California | 92618 | — |
| Omega Clinical Trials, LLC | La Habra | California | 90631 | — |
| Semel Institute for Neuroscience & Human Behavior at UCLA | Los Angeles | California | 90024 | — |
| Pacific Research Partners | Oakland | California | 94612 | — |
| North County Clinical Research | Oceanside | California | 92066 | — |
| Pasadena Research Institute, LLC | Pasadena | California | 91106 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| BreakThrough Clinical Trials, LLC | San Bernardino | California | 92408 | — |
| Affiliated Research Institute | San Diego | California | 92108 | — |
| PCSD - Feighner Research | San Diego | California | 92108 | — |
| Clinical Innovations, Inc. | San Diego | California | 92121 | — |
| Sharp Mesa Vista Hospital | San Diego | California | 92123' | — |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | — |
| Neuropsychiatric Center of Orange County | Santa Ana | California | 92701 | — |
| Caliifornia Neuroscience Research Medical Group | Sherman Oaks | California | 91403 | — |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | — |
| Western Affiliated Research Institute | Denver | Colorado | 80209 | — |
| Connecticut Clinical Research | Cromwell | Connecticut | 06416 | — |
| Geriatric and Adult Psychiatry, LLC | Hamden | Connecticut | 06518 | — |
| Institute of Living - Hartford Hospital | Hartford | Connecticut | 06106 | — |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | — |
| CNS Clinical Research Group | Coral Springs | Florida | 33067 | — |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | — |
| Emerald Coast Mood & Memory, PA | Fort Walton Beach | Florida | 32547 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | — |
| Amit Vijapura MD | Jacksonville | Florida | 32256 | — |
| Psychiatric Associates | Lake City | Florida | 32025 | — |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | — |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | — |
| Fidelity Clinical Research Inc | North Miami | Florida | 33161 | — |
| Scientific Clinical Research Inc. | North Miami | Florida | 33161 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Ali A. Kashfi, MD, PA | Orlando | Florida | 32889 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Comprehensive Clinical Development, Inc. | St. Petersburg | Florida | 33716 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | — |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | — |
| Kolin Research Group | Winter Park | Florida | 32789 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| Atlanta Institute of Medicine & Research | Atlanta | Georgia | 30328 | — |
| Carman Research | Smyrna | Georgia | 30080 | — |
| Institute for Behavioral Medicine, LLC | Smyrna | Georgia | 30080 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| American Medical Research, Inc. | Oakbrook Terrace | Illinois | 60523 | — |
| Psyichiatric Medicine Associates, LLC | Skokie | Illinois | 60076 | — |
| Sleep and Behavior Medicine Institute | Vernon Hills | Illinois | 60061 | — |
| Davis Clinic | Indianapolis | Indiana | 46250 | — |
| Pedia Research, LLC | Newburgh | Indiana | 47630 | — |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | — |
| Clinical Trials Technology, Inc. | Prairie Village | Kansas | 66206 | — |
| Heartland Research Associates | Wichita | Kansas | 67207 | — |
| MCM Clinical Research LLC | Florence | Kentucky | 41042 | — |
| Pedia Research, LLC | Owensboro | Kentucky | 42301 | — |
| Louisiana Clinical Research LLC | Shreveport | Louisiana | 71101 | — |
| 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 | — |
| Comprehensive Psyichatric Associates | Gladstone | Missouri | 64118 | — |
| The Center for Pharmaceutical Research PC | Kansas City | Missouri | 64114 | — |
| Private Practice - Howard J. Ilivicky | O'Fallon | Missouri | 63368 | — |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63301 | — |
| Mid-America Clinical Research | St Louis | Missouri | 63109 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Premier Psychiatric Research Institute | Lincoln | Nebraska | 68526 | — |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | — |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| CRI Worldwide, LLC | Willingboro | New Jersey | 08046 | — |
| Albuquerque Neuroscience Inc. | Albuquerque | New Mexico | 87109 | — |
| Brooklyn Medical Institutes | Brooklyn | New York | 11214 | — |
| Comprehensive Clinical Development, Inc. | Fresh Meadows | New York | 11366 | — |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | — |
| Clinilabs, Inc. | New York | New York | 10019 | — |
| Medical & Behavioral Health Research, PC | New York | New York | 10023 | — |
| Fieve Clinical Research | New York | New York | 10075 | — |
| Mount Sinai School of Medicine | New York | New York | 11029 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Sleep Medicine Centers of Western New York | West Seneca | New York | 14224 | — |
| Triangle Neuropsyhiatry | Durham | North Carolina | 27707 | — |
| Clinical Trials of America | Hickory | North Carolina | 28601 | — |
| Dr. Richard Weisler | Raleigh | North Carolina | 27609 | — |
| Northcoast Clinical Trials | Beachwood | Ohio | 44122 | — |
| Community Research, Inc. | Cincinnati | Ohio | 45227 | — |
| Ohio State University Department of Psychiatry | Columbus | Ohio | 43210 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Lindner Center for Hope | Mason | Ohio | 45040 | — |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | — |
| Neurology & Neuroscience Center of Ohio | Toledo | Ohio | 43623 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| SP Research, PPC dba Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | — |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| Paramount Clinical Research | Bridgeville | Pennsylvania | 15017 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Belmont Center for Comprehensive Treatment | Philadelphia | Pennsylvania | 19131 | — |
| CRI Worldwide LLC | Philadelphia | Pennsylvania | 19139 | — |
| UPMC Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | — |
| University Services | West Chester | Pennsylvania | 19380 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | — |
| Medical University of South Carolina, Anxiety Disorders Program | North Charleston | South Carolina | 29406 | — |
| Psychiatric Consultants, PC | Franklin | Tennessee | 37067 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | — |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | — |
| FutureSearch Clinical Trials, LP | Austin | Texas | 78731 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Future Search Trials of Dallas, LP | Dallas | Texas | 75231 | — |
| Pillar Clinical Research, LLC | Dallas | Texas | 75243 | — |
| Bay Area Clinical Services | Friendswood | Texas | 77546 | — |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Wharton Research Center, Inc. | Wharton | Texas | 77488 | — |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | — |
| Ericksen Research and Development | Clinton | Utah | 84015 | — |
| Alliance Research Group | Richmond | Virginia | 23236 | — |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98125 | — |
| Dean Foundation for Health, Research, and Education | Middleton | Wisconsin | 53562 | — |
| Independent Physician Consultants (dba IPC Research) | Waukesha | Wisconsin | 53188 | — |
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 72 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01436175, 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 13, 2021 · Synced May 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01436175 live on ClinicalTrials.gov.