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Completed Phase 3 Interventional

Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder

ClinicalTrials.gov ID: NCT00467402

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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 9:09 AM EDT

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

Study identification

NCT ID
NCT00467402
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
644 participants

Conditions and interventions

Interventions

  • agomelatine Drug
  • placebo Drug

Drug

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
Mar 31, 2007
Primary completion
Aug 31, 2009
Completion
Not listed
Last update posted
Dec 22, 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 22, 2020 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00467402 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →