Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
NCT ID: NCT01110889
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
582 participants
INTERVENTIONAL
2010-05-31
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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AGO178C 0.5 mg /day
Agomelatine (AGO178C)
AGO178C 1 mg / day
Agomelatine (AGO178C)
Placebo
Placebo
Interventions
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Agomelatine (AGO178C)
Agomelatine (AGO178C)
Placebo
Eligibility Criteria
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Inclusion Criteria
* Current episode ≥4 weeks.
* CGI-Severity score ≥4 at Screening and Baseline.
Exclusion Criteria
* Any other current Axis I disorder other than MDD 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.
* Prior exposure to agomelatine.
* Female patients of childbearing potential who are not using effective contraception.
18 Years
70 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
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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Birmingham Psychiatry
Birmingham, Alabama, United States
Southwestern Research Institute
Beverly Hills, California, United States
Pharmacology Research Institute
Encino, California, United States
Mood & Anxiety Research
Fresno, California, United States
Excell Research, Inc
Oceanside, California, United States
Cnri-La, Llc
Pico Rivera, California, United States
CNRI San Diego
San Diego, California, United States
University of California San Diego Medical Center
San Diego, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Clinical Research Institute of South Florida
Hialeah, Florida, United States
Florida Clinical Research Center LLC
Maitland, Florida, United States
CNS Healthcare
Orlando, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
Quantum Lab. N. Broward Memory Disorder Center
Pompano Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, United States
Mountain West Clinical Trials
Eagle, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Psychiatric Associates
Overland Park, Kansas, United States
CTT Clinical Trials Technology
Prairie Village, Kansas, United States
Clinical Trials Management
Metairie, Louisiana, United States
Mount Auburn Medical Associates
Watertown, Massachusetts, United States
Coastal Research Associates
Weymouth, Massachusetts, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, United States
Psychopharmacology Research Association of Princeton
Princeton, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
Neurological Associates Of Albany, P.C.
Albany, New York, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Odyssey Research Services
Fargo, North Dakota, United States
The Ohio State University - Harding Hospital
Columbus, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Cutting Edge Research
Oklahoma City, Oklahoma, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Psychiatric Consultants
Franklin, Tennessee, United States
KRK Medical Research
Dallas, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Texas Center for Drug Development
Houston, Texas, United States
Alliance Research Group, LLC
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Inspira Clinical Research
San Juan, , Puerto Rico
Countries
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Related Links
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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6663
Other Identifiers
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CAGO178C2301
Identifier Type: -
Identifier Source: org_study_id