Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Public ClinicalTrials.gov record NCT00411099. 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
An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
Study identification
- NCT ID
- NCT00411099
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 508 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
- Nov 30, 2006
- Primary completion
- Dec 31, 2007
- Completion
- Not listed
- Last update posted
- Dec 22, 2020
Started 2006
United States locations
- U.S. sites
- 42
- U.S. states
- 24
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Scottsdale | Arizona | 85251 | — |
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | — |
| Novartis Investigative Site | Cerritos | California | 90703 | — |
| Novartis Investigative Site | El Centro | California | 92243 | — |
| Novartis Investigative Site | Garden Grove | California | 92845 | — |
| Novartis Investigative Site | Irvine | California | 92618 | — |
| Novartis Investigative Site | Lafayette | California | 94549 | — |
| Novartis Investigative Site | San Diego | California | 92126 | — |
| Novartis Investigative Site | Temecula | California | 92591 | — |
| Novartis Investigative Site | Cromwell | Connecticut | 06416 | — |
| Novartis Investigative Site | Hamden | Connecticut | 06518 | — |
| Novartis Investigative Site | Bradenton | Florida | 34208 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32216 | — |
| Novartis Investigative Site | Maitland | Florida | 32751 | — |
| Novartis Investigative Site | Port Charlotte | Florida | 33952 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30308 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30329 | — |
| Novartis Investigative Site | Marietta | Georgia | 30060 | — |
| Novartis Investigative Site | Overland Park | Kansas | 66212 | — |
| Novartis Investigative Site | Rockville | Maryland | 20852 | — |
| Novartis Investigative Site | Salisbury | Maryland | 21801 | — |
| Novartis Investigative Site | Pittsfield | Massachusetts | 01201 | — |
| Novartis Investigative Site | Farmington Hills | Michigan | 48336 | — |
| Novartis Investigative Site | Rochester Hills | Michigan | 48307 | — |
| Novartis Investigative Site | City of Saint Peters | Missouri | 63376 | — |
| Novartis Investigative Site | Princeton | New Jersey | 08540 | — |
| Novartis Investigative Site | Albuquerque | New Mexico | 87102 | — |
| Novartis Investigative Site | Brooklyn | New York | 11235 | — |
| Novartis Investigative Site | New York | New York | 10021 | — |
| Novartis Investigative Site | Beachwood | Ohio | 44122 | — |
| Novartis Investigative Site | Dayton | Ohio | 45408 | — |
| Novartis Investigative Site | Tulsa | Oklahoma | 74136 | — |
| Novartis Investigative Site | Eugene | Oregon | 97404 | — |
| Novartis Investigative Site | North Charleston | South Carolina | 29406 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | — |
| Novartis Investigative Site | Austin | Texas | 78754 | — |
| Novartis Investigative Site | Dallas | Texas | 75231 | — |
| Novartis Investigative Site | Houston | Texas | 77007 | — |
| Novartis Investigative Site | Salt Lake City | Utah | 84107 | — |
| Novartis Investigative Site | Bennington | Vermont | 05201 | — |
| Novartis Investigative Site | Midlothian | Virginia | 23112 | — |
| Novartis Investigative Site | Bothell | Washington | 98011 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00411099, 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 22, 2020 · Synced Sep 7, 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 NCT00411099 live on ClinicalTrials.gov.