Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
NCT ID: NCT00411242
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
503 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
Mesa, Arizona, United States
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Los Angeles, California, United States
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Oceanside, 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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San Diego, California, United States
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Denver, Colorado, United States
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Smyrna, Georgia, United States
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Hoffman Estates, Illinois, United States
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Hoffman Estates, Illinois, United States
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Park Ridge, Illinois, United States
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Skokie, Illinois, United States
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Prairie Village, Kansas, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Glen Burnie, Maryland, United States
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Las Vegas, Nevada, United States
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Kenilworth, New Jersey, United States
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Summit, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Cedarhurst, New York, United States
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Fresh Meadows, 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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Staten Island, New York, United States
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West Allis, New York, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Arlington, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
Countries
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References
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Stahl SM, Fava M, Trivedi MH, Caputo A, Shah A, Post A. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry. 2010 May;71(5):616-26. doi: 10.4088/JCP.09m05471blu. Epub 2010 Mar 23.
Related Links
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Results for CAGO178A2302 from the Novartis Clinical Trials website
Other Identifiers
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CAGO178A2302
Identifier Type: -
Identifier Source: org_study_id