Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)



Status:Archived
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2010

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Trial Summary
Trial Overview
Inclusion Criteria

A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)


The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual
(under the tongue) formulation of agomelatine in patients with Major Depressive Disorder
over a 52-week open-label phase.

Cohort I is restricted to include patients who have completed a previous Novartis
agomelatine (178C) Double-blind study.

Cohort II will include de-novo patients (those who did not participate in a previous
agomelatine 178C study) and will only be open for a limited time span ranging from
approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.



We found this trial at
102
sites
VCU Medical Center
1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Emory University
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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University of Cincinnati Medical Center
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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Northwest Clinical Research Center
1952 - 152nd Place NE
East Seattle, Washington 98007
425-453-0404
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East Seattle, WA
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MD Clinical
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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Sunstone Medical Research, LLC
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
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Medford, OR
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CRI Worldwide
16000 Horizon Way Mount
Mt Laurel, New Jersey 08054
856-533-5020
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Alliance Research Group
3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
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Richmond, VA
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UCSF Helen Diller Family Comprehensive Cancer Center
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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Miami Research Associates
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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InSite Clinical Research
941 York Drive DeSoto
Southwest, Texas 75115
214-477-5162
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Janus Center for Psychiatric Research
5601 Corporate Way
West Palm Beach, Florida 33407
561-238-3036
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Albuquerque Neuroscience Inc.
Albuquerque, New Mexico 87109
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Albuquerque, NM
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Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
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ICSL Clinical Studies
Altamonte Springs, Florida 32701
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Millwood Hospital
Arlington, Texas 76011
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Pharmasite Research
Baltimore, Maryland 21208
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Sheppard Pratt Health System
Baltimore, Maryland 21285
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Southwestern Research Institute
Beverly Hills, California 90210
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Boston Clinical Trials, INC.
Boston, Massachusetts 02135
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University of Colorado, Boulder
Boulder, Colorado 80309
(303) 492-1411
University of Colorado, Boulder As the flagship university of the state of Colorado, CU-Boulder is...
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Florida Clinical Research Center, LLC
8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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Social Psychiatric Research Institute
Brooklyn, New York 11235
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Neuro-Behavioral Cilnical Research Inc
Canton, Ohio 44718
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Neurobehavioral Research, Inc.
Cedarhurst, New York 11516
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Comprehensive NeuroScience
Cerritos, California 90703
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Metro Health Medical Center
Cleveland, Ohio 44109
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North Star Medical Research
Cleveland, Ohio 44130
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Arocha Research Center
Coral Gables, Florida 33134
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ATP Clinical Research, Inc.
Costa Mesa, California 92626
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FutureSearch Clinical Trials, LP
Dallas, Texas 75231
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Western Affiliated Research Institute
Denver, Colorado 80204
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Michigan State University
East Lansing, Michigan 48824
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Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois 60007
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Odyssey Research Services
Fargo, North Dakota 58104
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SJS Clinical Research
Fort Walton Beach, Florida 32547
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Psychiatric Consultants
Franklin, Tennessee 37067
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Franklin, TN
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Collaborative Neuroscience Network
Garden Grove, California 92845
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Advanced Research Associates
Glendale, Arizona 85308
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Glendale, AZ
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Pine Rest Christian Mental Health Services
Grand rapids, Michigan 49548
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Grand rapids, MI
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Pharmquest
Greensboro, North Carolina 27408
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Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois 60169
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Hawaii Clinical Research Center
Honolulu, Hawaii 96813
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Honolulu, HI
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Claghorn-Lesem Research Clinic
Houston, Texas 77008
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Houston, TX
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Bayou City Research Limited
Houston, Texas 77007
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Goldpoint Clinical Research
Indianapolis, Indiana 46260
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Indianapolis, IN
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Clinical Neuroscience Solution, Inc.
Jacksonville, Florida 32216
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Jacksonville, FL
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Joliet Center for Clinical Research
Joliet, Illinois 60435
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Joliet, IL
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Dynamic Clinical Research, Inc.
Kansas City, Missouri 64114
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Independent Clinical Researchers
Las Vegas, Nevada 89106
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Capstone Clinical Research
Libertyville, Illinois 60048
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Premier Psychiatry Group, LLC
Lincoln, Nebraska 68510
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Lincoln, NE
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Clinical Study Centers, LLC
Little Rock, Arkansas 72205
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Little Rock, AR
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Florida Clinical Research Center LLC
Maitland, Florida 32751
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Suburban Research Associates
Media, Pennsylvania 19063
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Media, PA
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Research Strategies
Memphis, Tennessee 38119
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Clinical Trials Management
Metairie, Louisiana 70006
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Middlesex Hospital
Middletown, Connecticut 06457
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Clinical Research Associates
Nashville, Tennessee 37203
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UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, New Jersey 08901
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Medical & Behavioral Health Research
New York, New York 10023
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The Medical Research Network, LLC
New York, New York 10128
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Eastside Comprehensive Medical Service
New York, New York 10021
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Deaconess Clinic Gateway
Newburgh, Indiana 47630
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Pharmacology Research Institute
Newport Beach, California 92660
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Newport Beach, CA
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Cutting Edge Research
Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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IPS Research
Oklahoma City, Oklahoma 73103
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Red River Medical Research
Oklahoma City, Oklahoma 73112
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SP Research, PLLC
Oklahoma City, Oklahoma 73112
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Pacific Clinical Research Medical Group
Orange, California 92868
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Uc Irvine Medical Center
Orange, California 92868
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CNS Healthcare
Orlando, Florida 32806
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CRI Worldwide, LLC
Philadelphia, Pennsylvania 19139
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Philadelphia, PA
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Southwest Health Ltd
Phoenix, Arizona 85254
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CNS Clinical Research
Pompano Beach, Florida 33067
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Quantum Lab. at N. Broward Memory Disorder Center
Pompano Beach, Florida 33064
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Oregon Center for Clinical Investigations, Inc.
Portland, Oregon 97210
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Portland, OR
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Summit Research Network
Portland, Oregon 97210
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Portland, OR
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Zarzar Psychiatric Associates, PLLC
Raleigh, North Carolina 27607
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Raleigh, NC
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Rochester Center for Behavioral Medicine
Rochester Hills, Michigan 48307
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Rochester Hills, MI
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Northwest Behavioral Research Center
Roswell, Georgia 30076
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Roswell, GA
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Radiant Research
Salt Lake City, Utah 84107
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University Of Utah Hospital
Salt Lake City, Utah 84132
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California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California 92102
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San Diego, CA
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Neuropsychiatric Research Center of Orange County
Santa Ana, California 92701
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Santa Ana, CA
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Rush University - Psychiatric Medicine Associates
Skokie, Illinois 60076
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Skokie, IL
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Frontier Institute
Spokane, Washington 99204
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Spokane, WA
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Neurology Clinic of St. Cloud
St. Cloud, Minnesota 56303
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St. Cloud, MN
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Comprehensive NeuroScience, Inc.
St. Petersburg, Florida 33716
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St. Petersburg, FL
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Richmond Behavioral Associates
Staten Island, New York 10312
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Staten Island, NY
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Viking Clinical Research
Temecula, California 92591
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Temecula, CA
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BioBehavioral Health
Toms River, New Jersey 08755
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Collaborative Neuroscience Network, INC
Torrance, California 90502
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Torrance, CA
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Brighton Research Group, LLC
Virginia Beach, Virginia 23452
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Coastal Research Associates
Weymouth, Massachusetts 02190
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Grayline Clinical Drug Trials
Wichita Falls, Texas 76309
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