Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
Public ClinicalTrials.gov record NCT01110889. 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.
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Official title
An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
Study identification
- NCT ID
- NCT01110889
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 582 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 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 2010 (Type not available)
- Primary completion
- Jul 2011 (Actual)
- Completion
- Not listed
- Last update posted
- Dec 23, 2020
Started 2010
United States locations
- U.S. sites
- 47
- U.S. states
- 24
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Psychiatry | Birmingham | Alabama | 25226 | — |
| Southwestern Research Institute | Beverly Hills | California | 90210 | — |
| Pharmacology Research Institute | Encino | California | 91316 | — |
| Mood & Anxiety Research | Fresno | California | 93720 | — |
| Excell Research, Inc | Oceanside | California | 92056 | — |
| Cnri-La, Llc | Pico Rivera | California | 90660 | — |
| CNRI San Diego | San Diego | California | 92102 | — |
| University of California San Diego Medical Center | San Diego | California | 92103 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Western Affiliated Research Institute | Denver | Colorado | 80204 | — |
| Clinical Research Institute of South Florida | Hialeah | Florida | 33013 | — |
| Florida Clinical Research Center LLC | Maitland | Florida | 32751 | — |
| CNS Healthcare | Orlando | Florida | 32806 | — |
| Broward Research Group | Pembroke Pines | Florida | 33026 | — |
| Quantum Lab. N. Broward Memory Disorder Center | Pompano Beach | Florida | 33064 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | — |
| Hawaii Clinical Research Center | Honolulu | Hawaii | 96813 | — |
| Mountain West Clinical Trials | Eagle | Idaho | 83616 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Psychiatric Associates | Overland Park | Kansas | 66211 | — |
| CTT Clinical Trials Technology | Prairie Village | Kansas | 66206 | — |
| Clinical Trials Management | Metairie | Louisiana | 70006 | — |
| Mount Auburn Medical Associates | Watertown | Massachusetts | 02472 | — |
| Coastal Research Associates | Weymouth | Massachusetts | 02190 | — |
| Comprehensive Psychiatric Associates | Gladstone | Missouri | 64114 | — |
| Psychopharmacology Research Association of Princeton | Princeton | New Jersey | 08540 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Albuquerque Neuroscience | Albuquerque | New Mexico | 87109 | — |
| Neurological Associates Of Albany, P.C. | Albany | New York | 12208 | — |
| Neurobehavioral Research Inc. | Cedarhurst | New York | 11516 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Odyssey Research Services | Fargo | North Dakota | 58104 | — |
| The Ohio State University - Harding Hospital | Columbus | Ohio | 43210 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Cutting Edge Research | Oklahoma City | Oklahoma | 73116 | — |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| Psychiatric Consultants | Franklin | Tennessee | 37067 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Texas Center for Drug Development | Houston | Texas | 77081 | — |
| Alliance Research Group, LLC | Richmond | Virginia | 23230 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01110889, 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 23, 2020 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01110889 live on ClinicalTrials.gov.