A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
NCT ID: NCT00463242
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
501 participants
INTERVENTIONAL
2007-03-31
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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Agomelatine
Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.
Agomelatine
Either 25 mg or 50 mg agomelatine orally once daily
2
paroxetine
3
placebo
Interventions
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Agomelatine
Either 25 mg or 50 mg agomelatine orally once daily
paroxetine
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Major Depressive Disorder according to DSM-IV criteria
* HAM-D17 total score \> or = 22 at Screening and Baseline
Exclusion Criteria
* Patients who have been previously treated with agomelatine
* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
* 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
* 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
Phoenix, Arizona, United States
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National City, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Pico Rivera, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
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Boca Raton, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Augusta, Georgia, United States
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Honolulu, Hawaii, United States
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Joliet, Illinois, United States
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Overland Park, Kansas, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Fall River, Massachusetts, United States
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Okemos, Michigan, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Willingboro, New Jersey, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Canton, Ohio, United States
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Corvallis, Oregon, United States
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Erie, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Friendswood, Texas, United States
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Houston, Texas, United States
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Herndon, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Waukesha, Wisconsin, United States
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Hato Rey, , Puerto Rico
Countries
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Related Links
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Results for CAGO178A2303 from the Novartis Clinical Trials website
Other Identifiers
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CAGO178A2303
Identifier Type: -
Identifier Source: org_study_id