Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
Public ClinicalTrials.gov record NCT01156415. 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 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study. Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
Study identification
- NCT ID
- NCT01156415
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 837 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 71 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
- Jun 2010 (Type not available)
- Primary completion
- Oct 2011 (Actual)
- Completion
- Oct 2011 (Actual)
- Last update posted
- Dec 24, 2020
2010 – 2011
United States locations
- U.S. sites
- 95
- U.S. states
- 31
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Advanced Research Associates | Glendale | Arizona | 85308 | — |
| Southwest Health Ltd dba The Mollen Clinic | Scottsdale | Arizona | 85254 | — |
| Clinical Study Centers, LLC | Little Rock | Arkansas | 72205 | — |
| Southwestern Research Institute | Beverly Hills | California | 90210 | — |
| Comprehensive Neuroscience | Cerritos | California | 90703 | — |
| ATP Clinical Research, Inc | Costa Mesa | California | 92626 | — |
| Collaborative Neuroscience Network | Garden Grove | California | 92845 | — |
| Pharmacology Research Institute | Newport Beach | California | 92660 | — |
| Pacific Clinical Research Medical Group | Orange | California | 92868 | — |
| CNRI-San Diego, LLC | San Diego | California | 92102 | — |
| University of California, San Diego Medical Center | San Diego | California | 92103 | — |
| Neuropsychiatric Research Center of Orange County | Santa Ana | California | 92701 | — |
| Viking Clinical Research Center | Temecula | California | 92591 | — |
| Collaborative Neuroscience | Torrance | California | 90502 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Western Affiliated Research Institute | Denver | Colorado | 80209 | — |
| Middlesex Hospital | Middletown | Connecticut | 06457 | — |
| Clinical Studies | Altamonte Springs | Florida | 32701 | — |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34208 | — |
| Arocha Research Center | Coral Gables | Florida | 33134 | — |
| CNS Clinical Research | Coral Springs | Florida | 33067 | — |
| Sjs Clinical Research | Destin | Florida | 32541 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| CNS Healthcare | Jacksonville | Florida | 32216 | — |
| Florida Clinical Research Center | Maitland | Florida | 34201 | — |
| CNS Healthcare | Orlando | Florida | 32806 | — |
| Quantum Lab. at N. Broward Memory Disorder Center | Pompano Beach | Florida | 33064 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Comprehensive NeuroScience, Inc. | St. Petersburg | Florida | 33716 | — |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | — |
| Emory University | Atlanta | Georgia | 30306 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | — |
| Hawaii Clinical Research Center | Honolulu | Hawaii | 96813 | — |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| Joliet Center for Clinical Research | Joliet | Illinois | 60435 | — |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | — |
| Rush University Medical Center | Skokie | Illinois | 60076 | — |
| Deaconess Clinic Gateway | Newburgh | Indiana | 47630 | — |
| Pharmasite Research | Pikesville | Maryland | 21208 | — |
| Boston Clinical Trials | Boston | Massachusetts | 02135 | — |
| Mount Auburn Medical Associates | Watertown | Massachusetts | 02472 | — |
| Coastal Research Associates | Weymouth | Massachusetts | 02190 | — |
| Michigan State University | East Lansing | Michigan | 48824 | — |
| Pine Rest Christian Mental Health Services | Grand Rapids | Michigan | 49548 | — |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | — |
| Comprehensive Psychiatric Associates | Gladstone | Missouri | 64118 | — |
| Robert Wood Johnson Medical School | Piscataway | New Jersey | 08854 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| CRI Worldwide | Willingboro | New Jersey | 08046 | — |
| Albuquerque Neuroscience | Albuquerque | New Mexico | 87109 | — |
| Neurological Associates Of Albany | Albany | New York | 12208 | — |
| Social Psychiatry Research, Inc./ SPRI | Brooklyn | New York | 11235 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| Eastside Comprehensive Medical Service | New York | New York | 10021 | — |
| Medical & Behavior Health Research | New York | New York | 10023 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Pharmquest | Greensboro | North Carolina | 27408 | — |
| Zarzar Psychiatric Associates | Raleigh | North Carolina | 27607 | — |
| Piedmont Medical Research Associates, Inc. | Winston-Salem | North Carolina | 27103 | — |
| Odyssey Research Services | Fargo | North Dakota | 58104 | — |
| Neuro Behavioral Clinical Research | Canton | Ohio | 44718 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| North Star Medical Research | Cleveland | Ohio | 44130 | — |
| The Ohio State Universtiy - Harding Hospital | Columbus | Ohio | 43210 | — |
| Neurology & Neuroscience Center of Ohio | Toledo | Ohio | 43623 | — |
| IPS Research | Oklahoma City | Oklahoma | 73103 | — |
| SP Research | Oklahoma City | Oklahoma | 73112 | — |
| Cutting Edge Research | Oklahoma City | Oklahoma | 73116 | — |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | — |
| Oregon Center for Clinical Investigations | Portland | Oregon | 97210 | — |
| Summit Research | Portland | Oregon | 97210 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29406 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Research Strategies of Memphis | Memphis | Tennessee | 38119 | — |
| Clinical Research Associates | Nashville | Tennessee | 37203 | — |
| Millwood Hospital | Arlington | Texas | 76011 | — |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Bayou City Research Limited | Houston | Texas | 77007 | — |
| Claghorn Lesem Research Clinic, Inc. | Houston | Texas | 77008 | — |
| Texas Center for Drug Development | Houston | Texas | 77081 | — |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | — |
| Radiant Research | Salt Lake City | Utah | 84107 | — |
| University of Utah Mood Disorders Clinic | Salt Lake City | Utah | 84132 | — |
| Alliance Research Group, LLC | Richmond | Virginia | 23230 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Frontier Institute | Spokane | Washington | 99204 | — |
| Independent Psychiatric Consultants | 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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01156415, 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 24, 2020 · Synced Oct 22, 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 NCT01156415 live on ClinicalTrials.gov.