Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
NCT ID: NCT00411099
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
508 participants
INTERVENTIONAL
2006-12-31
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
TREATMENT
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
* HAM-D17 total score \> or = 22 at Screening and Baseline
* CGI-Severity score \> or = 4 at Screening and Baseline
* Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase
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
* Concomitant psychotropic medication, including herbal preparations and melatonin
* Psychotherapy of any type
* 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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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Cerritos, California, United States
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El Centro, California, United States
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Garden Grove, California, United States
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Irvine, California, United States
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Lafayette, California, United States
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San Diego, California, United States
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Temecula, California, United States
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Cromwell, Connecticut, United States
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Hamden, Connecticut, United States
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Bradenton, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Port Charlotte, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Overland Park, Kansas, United States
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Rockville, Maryland, United States
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Salisbury, Maryland, United States
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Pittsfield, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Rochester Hills, Michigan, United States
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City of Saint Peters, Missouri, United States
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Princeton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Beachwood, Ohio, United States
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Dayton, Ohio, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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North Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Bennington, Vermont, United States
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Midlothian, Virginia, United States
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Bothell, Washington, United States
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Bayamón, , Puerto Rico
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Rio Piedras, , Puerto Rico
Countries
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Related Links
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Results for CAGO178A2301 from the Novartis Clinical Trials website
Other Identifiers
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CAGO178A2301
Identifier Type: -
Identifier Source: org_study_id