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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00411242

Public ClinicalTrials.gov record NCT00411242. 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 Sep 6, 2026, 11:38 PM EDT

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 (CAGO178A2302E)

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
NCT00411242
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis
Industry
Enrollment
503 participants

Conditions and interventions

Interventions

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
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
51
U.S. states
22
U.S. cities
45
Facility City State ZIP Site status
Novartis Investigative Site Mesa Arizona 85210
Novartis Investigative Site Los Angeles California 90024
Novartis Investigative Site Oceanside California 92056
Novartis Investigative Site San Diego California 92103
Novartis Investigative Site San Diego California 92108
Novartis Investigative Site San Diego California 92123
Novartis Investigative Site Denver Colorado 80212
Novartis Investigative Site Daytona Beach Florida 32124
Novartis Investigative Site Fort Lauderdale Florida 33319
Novartis Investigative Site Miami Florida 33143
Novartis Investigative Site North Miami Florida 33161
Novartis Investigative Site North Miami Florida
Novartis Investigative Site Orlando Florida 32806
Novartis Investigative Site Atlanta Georgia 30328
Novartis Investigative Site Smyrna Georgia 30080
Novartis Investigative Site Hoffman Estates Illinois 60169
Novartis Investigative Site Hoffman Estates Illinois 60194
Novartis Investigative Site Park Ridge Illinois 60068
Novartis Investigative Site Skokie Illinois 60076
Novartis Investigative Site Prairie Village Kansas 66206
Novartis Investigative Site Topeka Kansas 66606
Novartis Investigative Site Wichita Kansas 67207
Novartis Investigative Site Shreveport Louisiana 71103
Novartis Investigative Site Glen Burnie Maryland 21061
Novartis Investigative Site Las Vegas Nevada 89128
Novartis Investigative Site Kenilworth New Jersey 07033
Novartis Investigative Site Summit New Jersey 07901
Novartis Investigative Site Toms River New Jersey 08755
Novartis Investigative Site Brooklyn New York 11201
Novartis Investigative Site Cedarhurst New York 11516
Novartis Investigative Site Fresh Meadows New York 11366
Novartis Investigative Site New York New York 10021
Novartis Investigative Site New York New York 10023
Novartis Investigative Site Staten Island New York 10312
Novartis Investigative Site West Allis New York 53227
Novartis Investigative Site Raleigh North Carolina 27609
Novartis Investigative Site Cleveland Ohio 44122
Novartis Investigative Site Toledo Ohio 43623
Novartis Investigative Site Oklahoma City Oklahoma 73103
Novartis Investigative Site Medford Oregon 97504
Novartis Investigative Site Portland Oregon 97210
Novartis Investigative Site Philadelphia Pennsylvania 19104
Novartis Investigative Site Memphis Tennessee 38119
Novartis Investigative Site Austin Texas 78756
Novartis Investigative Site Houston Texas 77008
Novartis Investigative Site Houston Texas 77090
Novartis Investigative Site Irving Texas 75062
Novartis Investigative Site Arlington Virginia 22201
Novartis Investigative Site Bellevue Washington 98004
Novartis Investigative Site Seattle Washington 98104
Novartis Investigative Site Milwaukee 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 NCT00411242, 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 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00411242 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →