A Paroxetine- and Placebo-Controlled Study of 50 mg/Day and 100 mg/Day of EB-1010 Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
Open the official record
This page only displays public information reproduced from the official ClinicalTrials.gov record NCT01318434. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Paroxetine- and Placebo-Controlled Study of 50 mg/Day and 100 mg/Day of EB-1010 Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (Triple Reuptake Inhibitor Anti-Depressant Effects - TRIADE Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main research hypothesis for this study is that, among patients with Major Depressive Disorder (MDD) who have responded inadequately to treatment with SSRIs or SNRIs, the degree of improvement, as measured by the change from baseline of the Montgomery-Asberg Depression Rating Scale (MADRS)will be significantly greater among patients treated with EB-1010 (at the dose of 50 mg/day or 100 mg/day) than among those treated with placebo using the sequential parallel comparison design. The secondary research hypothesis for this study is that, among patients with MDD who have responded inadequately to treatment with SSRIs or SNRIs, the degree of improvement in depressive symptoms, as assessed by the MGH Cognitive and Physical Functioning Questionnaire (MGH CPFQ) will be significantly greater among those treated with EB-1010 (50 mg/day or 100 mg/day) than those treated with the SSRI paroxetine.
Study identification
- NCT ID
- NCT01318434
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 342 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
- Feb 2011 (Type not available)
- Primary completion
- Feb 2013 (Actual)
- Completion
- Feb 2013 (Actual)
- Last update posted
- Dec 4, 2015
2011 – 2013
United States locations
- U.S. sites
- 43
- U.S. states
- 21
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pacific Clinical Research Medical Group | Arcadia | California | 91007 | — |
| Southwest Research, Inc. | Beverly Hills | California | 90210 | — |
| Synergy Clinical Research Center | National City | California | 91950 | — |
| Clinical Innovations, Inc. | Santa Ana | California | 92705 | — |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | — |
| Radiant Research, Inc. | Denver | Colorado | 80239 | — |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | — |
| Sanitas Research | Coral Gables | Florida | 33134 | — |
| Clinical Neuroscience Solution, Inc. | Jacksonville | Florida | 32216 | — |
| Florida Clinical Research Center | Maitland | Florida | 32751 | — |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32806 | — |
| Medical Research Group of Central Florida | Sanford | Florida | 32771 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| AMR Baber Research | Naperville | Illinois | 60563 | — |
| Psychiatric Medicine Associates | Stokie | Illinois | 60076 | — |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70601 | — |
| Clinical Insights | Glen Burnie | Maryland | 21061 | — |
| Cambridge Health Alliance | Cambridge | Massachusetts | 02139 | — |
| AccelRx Research | Fall River | Massachusetts | 02721 | — |
| St Charles Psychiatric Associates | Saint Charles | Missouri | 63301 | — |
| Global Medical Institutes | Princeton | New Jersey | 08540 | — |
| CRI Worldwide, LLC | Willingboro | New Jersey | 08046 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Behavioral Medical Research of Staten Island | Staten Island | New York | 10305 | — |
| Community Research | Cincinnati | Ohio | 45227 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| North Star Medical Research | Middleburg Heights | Ohio | 44130 | — |
| Neurology and Neuroscience Center of Ohio | Toledo | Ohio | 43623 | — |
| SP Research, PLLC | Oklahoma City | Oklahoma | 73112 | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | — |
| Southeastern PA Medical Institute | Broomall | Pennsylvania | 19008 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| CRI Worldwide | Philadelphia | Pennsylvania | 19139 | — |
| Scranton Counseling Center | Scranton | Pennsylvania | 18503 | — |
| Radiant Research | Greer | South Carolina | 29651 | — |
| Clinical NeuroScience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | — |
| Radiant Research, Inc. | Murray | Utah | 84123 | — |
| Aspen Clinical Research | Orem | Utah | 84058 | — |
| VCU | Richmond | Virginia | 23219 | — |
| Dean Foundation for Health, Research & Education | Middleton | Wisconsin | 53562 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01318434, 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 Dec 4, 2015 · Synced Nov 14, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.