Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
NCT ID: NCT00467402
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
644 participants
INTERVENTIONAL
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
agomelatine
2
agomelatine
3
placebo
Interventions
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agomelatine
placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
* A history of at least two previous episodes of Major Depression plus the current episode
* Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline
Exclusion Criteria
* Any current Axis I disorder other than major depressive disorder which is the focus of treatment
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
* Use of any psychoactive medication after the screening visit
* Patients who have been previously treated with agomelatine
* Female patients of childbearing potential who are not using effective contraception
18 Years
70 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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Peoria, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Costa Mesa, California, United States
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Encino, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Oceanside, California, United States
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Sacramento, California, United States
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Sherman Oaks, California, United States
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Temecula, California, United States
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Wheat Ridge, Colorado, United States
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Bradenton, Florida, United States
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Coral Springs, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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Venice, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Libertyville, Illinois, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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New Orleans, Louisiana, United States
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Rockville, Maryland, United States
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Towson, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Braintree, Massachusetts, United States
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Worcester, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Minneapolis, Minnesota, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Newark, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Rhododendron, Oregon, United States
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Allentown, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Edmonds, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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West Allis, Wisconsin, United States
Countries
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Related Links
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Results for CAGO178A2304 from the Novartis Clinical Trials website
Other Identifiers
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CAGO178A2304
Identifier Type: -
Identifier Source: org_study_id