Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
NCT ID: NCT01110902
Last Updated: 2020-12-24
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
589 participants
INTERVENTIONAL
2010-05-31
2011-06-30
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
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)
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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University of Alabama at Birmingham, Department of Psychiatry
Birmingham, Alabama, United States
ATP Clinical Research
Costa Mesa, California, United States
Valley Clinical Research
El Centro, California, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Anderson Clinical Research
Redlands, California, United States
Affiliated Research Institute
San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Viking Clinical Research
Temecula, California, United States
ICSL Clinical Studies
Altamonte Springs, Florida, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Arocha Research Center
Coral Gables, Florida, United States
Innova Clinical Trials
Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Joliet Center for Clinical Research
Joliet, Illinois, United States
CNS Clinical Trials
Park Ridge, Illinois, United States
Deaconess Clinic
Evansville, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Pharmasite Research
Pikesville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Clinical Trials
Brighton, Massachusetts, United States
Mercy Health Research
St Louis, Missouri, United States
Premier Psychiatry Group, LLC
Lincoln, Nebraska, United States
CRI Worldwide, LLC - Lourdes Division
Willingboro, New Jersey, United States
Social Psychiatric Research Institute
Brooklyn, New York, United States
Eastside Comprehensive Medical Service
New York, New York, United States
Neurobehavioral Clinical Research
Canton, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States
SP Research
Oklahoma City, Oklahoma, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Summit Research Network
Portland, Oregon, United States
CRI Worldwide, LLC - Kirkbride Division
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
CNS Healthcare
Memphis, Tennessee, United States
Research Strategies
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, United States
University of Utah, Department of Psychiatry
Salt Lake City, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research
Seattle, Washington, United States
Caribbean Research and Education Center
Bayamón, , Puerto Rico
Dharma Institute and Research Center
San Juan, , Puerto Rico
Countries
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Related Links
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Results for CAGO178C2302 from the Novartis Clinical Trials website
Click here for more information about this study:
Other Identifiers
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CAGO178C2302
Identifier Type: -
Identifier Source: org_study_id