Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
Public ClinicalTrials.gov record NCT00467402. 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, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.
Study identification
- NCT ID
- NCT00467402
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 644 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
- Apr 2007 (Type not available)
- Primary completion
- Sep 2009 (Actual)
- Completion
- Not listed
- Last update posted
- Dec 23, 2020
Started 2007
United States locations
- U.S. sites
- 78
- U.S. states
- 28
- U.S. cities
- 67
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35226 | — |
| Novartis Investigative Site | Peoria | Arizona | 85381 | — |
| Novartis Investigative Site | Tucson | Arizona | 85724 | — |
| Novartis Investigative Site | Beverly Hills | California | 90210 | — |
| Novartis Investigative Site | Costa Mesa | California | 92626 | — |
| Novartis Investigative Site | Encino | California | 91316 | — |
| Novartis Investigative Site | Glendale | California | 91206 | — |
| Novartis Investigative Site | Los Angeles | California | 90024 | — |
| Novartis Investigative Site | Newport Beach | California | 92660 | — |
| Novartis Investigative Site | Oceanside | California | 92056 | — |
| Novartis Investigative Site | Sacramento | California | 95817 | — |
| Novartis Investigative Site | Sherman Oaks | California | 91403 | — |
| Novartis Investigative Site | Temecula | California | 92591 | — |
| Novartis Investigative Site | Wheat Ridge | Colorado | 80033 | — |
| Novartis Investigative Site | Bradenton | Florida | 34208 | — |
| Novartis Investigative Site | Coral Springs | Florida | 33065 | — |
| Novartis Investigative Site | Fort Myers | Florida | 33912 | — |
| Novartis Investigative Site | Gainesville | Florida | 32607 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32216 | — |
| Novartis Investigative Site | St. Petersburg | Florida | 33702 | — |
| Novartis Investigative Site | Venice | Florida | 34285 | — |
| Novartis Investigative Site | West Palm Beach | Florida | 33407 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30328 | — |
| Novartis Investigative Site | Chicago | Illinois | 60611 | — |
| Novartis Investigative Site | Chicago | Illinois | 60640 | — |
| Novartis Investigative Site | Libertyville | Illinois | 60048 | — |
| Novartis Investigative Site | Overland Park | Kansas | 66211 | — |
| Novartis Investigative Site | Topeka | Kansas | 66606 | — |
| Novartis Investigative Site | New Orleans | Louisiana | 70114 | — |
| Novartis Investigative Site | Rockville | Maryland | 20852 | — |
| Novartis Investigative Site | Towson | Maryland | 21204 | — |
| Novartis Investigative Site | Towson | Maryland | 85724 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02135 | — |
| Novartis Investigative Site | Braintree | Massachusetts | 02184 | — |
| Novartis Investigative Site | Worcester | Massachusetts | 01605 | — |
| Novartis Investigative Site | Farmington Hills | Michigan | 48336 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55454 | — |
| Novartis Investigative Site | Kansas City | Missouri | 64111 | — |
| Novartis Investigative Site | Kansas City | Missouri | 66160 | — |
| Novartis Investigative Site | St Louis | Missouri | 63033 | — |
| Novartis Investigative Site | St Louis | Missouri | 63044 | — |
| Novartis Investigative Site | St Louis | Missouri | 63118 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68198 | — |
| Novartis Investigative Site | Newark | New Jersey | 07103 | — |
| Novartis Investigative Site | Albuquerque | New Mexico | 87102 | — |
| Novartis Investigative Site | Buffalo | New York | 14215 | — |
| Novartis Investigative Site | New York | New York | 10021 | — |
| Novartis Investigative Site | New York | New York | 10029 | — |
| Novartis Investigative Site | The Bronx | New York | 10467 | — |
| Novartis Investigative Site | Chapel Hill | North Carolina | 27599 | — |
| Novartis Investigative Site | Raleigh | North Carolina | 27609 | — |
| Novartis Investigative Site | Cleveland | Ohio | 44195 | — |
| Novartis Investigative Site | Columbus | Ohio | 43210 | — |
| Novartis Investigative Site | Toledo | Ohio | 43623 | — |
| Novartis Investigative Site | Portland | Oregon | 97210 | — |
| Novartis Investigative Site | Portland | Oregon | 97239 | — |
| Novartis Investigative Site | Rhododendron | Oregon | 97049 | — |
| Novartis Investigative Site | Allentown | Pennsylvania | 18104 | — |
| Novartis Investigative Site | Lansdale | Pennsylvania | 19446 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19139 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15213 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15238 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29412 | — |
| Novartis Investigative Site | Memphis | Tennessee | 38119 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37212 | — |
| Novartis Investigative Site | Austin | Texas | 78754 | — |
| Novartis Investigative Site | Austin | Texas | 78756 | — |
| Novartis Investigative Site | DeSoto | Texas | 75115 | — |
| Novartis Investigative Site | Houston | Texas | 77007 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
| Novartis Investigative Site | Houston | Texas | 77042 | — |
| Novartis Investigative Site | Lake Jackson | Texas | 77566 | — |
| Novartis Investigative Site | Richmond | Virginia | 23230 | — |
| Novartis Investigative Site | Virginia Beach | Virginia | 23230 | — |
| Novartis Investigative Site | Edmonds | Washington | 98026 | — |
| Novartis Investigative Site | Seattle | Washington | 98104 | — |
| Novartis Investigative Site | Milwaukee | Wisconsin | 53226 | — |
| Novartis Investigative Site | West Allis | Wisconsin | 53227 | — |
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 NCT00467402, 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 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 NCT00467402 live on ClinicalTrials.gov.