SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Public ClinicalTrials.gov record NCT01435759. 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 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging 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. 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?
Study identification
- NCT ID
- NCT01435759
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,197 participants
Conditions and interventions
Conditions
Interventions
- 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
- Antidepressant + Placebo 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
- May 31, 2011 (Actual)
- Primary completion
- Jan 17, 2014 (Actual)
- Completion
- Jan 17, 2014 (Actual)
- Last update posted
- Jun 9, 2021
2011 – 2014
United States locations
- U.S. sites
- 60
- U.S. states
- 22
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Psychiatric Clinic Clinical Research Trials | Little Rock | Arkansas | 72223 | — |
| South Coast Clinical Trials | Anaheim | California | 92804 | — |
| Catalina Research Institute, LLC | Chino | California | 91710 | — |
| Shanti Clinical Trials | Colton | California | 92324 | — |
| Clinical Innovation, Inc. | Costa Mesa | California | 92626 | — |
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | — |
| Irvine Center for Clinical Research | Irvine | California | 92618 | — |
| Omega Clinical Trials | La Habra | California | 90631 | — |
| Provate Practice of Andrew Leuchter, MD | Los Angeles | California | 90024 | — |
| PCSD - Feighner Research | San Diego | California | 92108 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | — |
| Neuropsychiatric Research Center of Orange County | Santa Ana | California | 92701 | — |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | — |
| Western Affiliated Research Institute | Denver | Colorado | 80209 | — |
| Connecticut Clinical Research | Cromwell | Connecticut | 06416 | — |
| Institute of Living | Hartford | Connecticut | 06106 | — |
| The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research | New Britain | Connecticut | 06050 | — |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | — |
| Private Practice - Amit Vijapura MD | Jacksonville | Florida | 32256 | — |
| Psychiatric Associates | Lake City | Florida | 32025 | — |
| Comprehensive Neuroscience, Inc. | Miramar | Florida | 33027 | — |
| Fideltiy Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Ali A. Kashfi, MD, PA | Orlando | Florida | 32839 | — |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | — |
| Kolin Research Group | Winter Park | Florida | 32789 | — |
| Institute for Behavioral Medicine, LLC | Smyrna | Georgia | 30080 | — |
| Treatment Research Center, Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| Psychiatric Medicine Associates, LLC | Skokie | Illinois | 60076 | — |
| Sleep and Behavior Medicine Institute | Vernon Hills | Illinois | 60061 | — |
| Clinical Trials Technology, Inc. | Prairie Village | Kansas | 66206 | — |
| Pedia Research, LLC | Owensboro | Kentucky | 42301 | — |
| Psyichatric Care and Research Center | O'Fallon | Missouri | 63368 | — |
| Mid-America Clinical Research, LLC | St Louis | Missouri | 63109 | — |
| Premier Psychiatric Research Institute, LLC. | Lincoln | Nebraska | 68526 | — |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | — |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| CRI Worldwide LLC | Willingboro | New Jersey | 08046 | — |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87109 | — |
| Clinlabs, Inc. | New York | New York | 10010 | — |
| Mount Sinai School of Medicine | New York | New York | 11029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Private Practice - Daniel I. Rifkin MD PC | West Seneca | New York | 14224 | — |
| Clinical Trials of America, Inc. | Hickory | North Carolina | 28601 | — |
| North Coast Clinical Trials, Inc. | Beachwood | Ohio | 44122 | — |
| Ohio State University, Dept. of Psychiatry | Columbus | Ohio | 43210 | — |
| Neurology & Neuroscience Center of Ohio | Toledo | Ohio | 43623 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University Services | West Chester | Pennsylvania | 19380 | — |
| Pillar Clinical Research, LLC | Dallas | Texas | 75243 | — |
| Bay Area Clinical Services | Friendswood | Texas | 77546 | — |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | — |
| Wharton Research Center, Inc. | Wharton | Texas | 77488 | — |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | — |
| Alliance Research Group | Richmond | Virginia | 23230 | — |
| Dean Foundation for Health, Research and Education, Inc. | Middleton | Wisconsin | 53562 | — |
| Independent Psychiatric Consultants, SC, 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 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01435759, 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 26, 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 public registry record, listed eligibility criteria, and available contact information for NCT01435759 live on ClinicalTrials.gov.