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
Red River Medical Research
Oklahoma City, Oklahoma 73112
1519
mi
from 98109
Oklahoma City, OK
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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,...
2178
mi
from 98109
Atlanta, GA
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
2080
mi
from 98109
Birmingham, AL
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
2485
mi
from 98109
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...
2402
mi
from 98109
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
1963
mi
from 98109
Cincinnati, OH
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Northwest Clinical Research Center
1952 - 152nd Place NE
East Seattle, Washington 98007
425-453-0404
9
mi
from 98109
East Seattle, WA
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MD Clinical
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
2723
mi
from 98109
Hallandale Beach, FL
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Sunstone Medical Research, LLC
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
368
mi
from 98109
Medford, OR
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CRI Worldwide
16000 Horizon Way Mount
Mt Laurel, New Jersey 08054
856-533-5020
2384
mi
from 98109
Mt Laurel, NJ
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Alliance Research Group
3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
2349
mi
from 98109
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...
680
mi
from 98109
San Francisco, CA
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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...
2730
mi
from 98109
South Miami, FL
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InSite Clinical Research
941 York Drive DeSoto
Southwest, Texas 75115
214-477-5162
1684
mi
from 98109
Southwest, TX
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Janus Center for Psychiatric Research
5601 Corporate Way
West Palm Beach, Florida 33407
561-238-3036
2688
mi
from 98109
West Palm Beach, FL
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Albuquerque Neuroscience Inc.
Albuquerque, New Mexico 87109
1183
mi
from 98109
Albuquerque, NM
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Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
2335
mi
from 98109
Allentown, PA
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ICSL Clinical Studies
Altamonte Springs, Florida 32701
2541
mi
from 98109
Altamonte Springs, FL
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Millwood Hospital
Arlington, Texas 76011
1670
mi
from 98109
Arlington, TX
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Pharmasite Research
Baltimore, Maryland 21208
2320
mi
from 98109
Baltimore, MD
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Sheppard Pratt Health System
Baltimore, Maryland 21285
2324
mi
from 98109
Baltimore, MD
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Southwestern Research Institute
Beverly Hills, California 90210
957
mi
from 98109
Beverly Hills, CA
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Boston Clinical Trials, INC.
Boston, Massachusetts 02135
2485
mi
from 98109
Boston, MA
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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...
989
mi
from 98109
Boulder, CO
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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,...
2545
mi
from 98109
Bradenton, FL
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Social Psychiatric Research Institute
Brooklyn, New York 11235
2408
mi
from 98109
Brooklyn, NY
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Neuro-Behavioral Cilnical Research Inc
Canton, Ohio 44718
2052
mi
from 98109
Canton, OH
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Neurobehavioral Research, Inc.
Cedarhurst, New York 11516
2417
mi
from 98109
Cedarhurst, NY
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Comprehensive NeuroScience
Cerritos, California 90703
976
mi
from 98109
Cerritos, CA
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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...
2422
mi
from 98109
Charleston, SC
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Metro Health Medical Center
Cleveland, Ohio 44109
2021
mi
from 98109
Cleveland, OH
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North Star Medical Research
Cleveland, Ohio 44130
2020
mi
from 98109
Cleveland, OH
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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...
2006
mi
from 98109
Columbus, OH
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Arocha Research Center
Coral Gables, Florida 33134
2729
mi
from 98109
Coral Gables, FL
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ATP Clinical Research, Inc.
Costa Mesa, California 92626
991
mi
from 98109
Costa Mesa, CA
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FutureSearch Clinical Trials, LP
Dallas, Texas 75231
1678
mi
from 98109
Dallas, TX
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Western Affiliated Research Institute
Denver, Colorado 80204
1019
mi
from 98109
Denver, CO
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Michigan State University
East Lansing, Michigan 48824
1855
mi
from 98109
East Lansing, MI
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Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois 60007
1712
mi
from 98109
Elk Grove Village, IL
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Odyssey Research Services
Fargo, North Dakota 58104
1192
mi
from 98109
Fargo, ND
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SJS Clinical Research
Fort Walton Beach, Florida 32547
2225
mi
from 98109
Fort Walton Beach, FL
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Psychiatric Consultants
Franklin, Tennessee 37067
1980
mi
from 98109
Franklin, TN
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Collaborative Neuroscience Network
Garden Grove, California 92845
982
mi
from 98109
Garden Grove, CA
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Advanced Research Associates
Glendale, Arizona 85308
1100
mi
from 98109
Glendale, AZ
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Pine Rest Christian Mental Health Services
Grand rapids, Michigan 49548
1796
mi
from 98109
Grand rapids, MI
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Pharmquest
Greensboro, North Carolina 27408
2295
mi
from 98109
Greensboro, NC
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Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois 60169
1704
mi
from 98109
Hoffman Estates, IL
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Hawaii Clinical Research Center
Honolulu, Hawaii 96813
2679
mi
from 98109
Honolulu, HI
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Claghorn-Lesem Research Clinic
Houston, Texas 77008
1887
mi
from 98109
Houston, TX
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Bayou City Research Limited
Houston, Texas 77007
1888
mi
from 98109
Houston, TX
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Goldpoint Clinical Research
Indianapolis, Indiana 46260
1862
mi
from 98109
Indianapolis, IN
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Clinical Neuroscience Solution, Inc.
Jacksonville, Florida 32216
2457
mi
from 98109
Jacksonville, FL
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Joliet Center for Clinical Research
Joliet, Illinois 60435
1720
mi
from 98109
Joliet, IL
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Dynamic Clinical Research, Inc.
Kansas City, Missouri 64114
1507
mi
from 98109
Kansas City, MO
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Independent Clinical Researchers
Las Vegas, Nevada 89106
872
mi
from 98109
Las Vegas, NV
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Capstone Clinical Research
Libertyville, Illinois 60048
1706
mi
from 98109
Libertyville, IL
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Premier Psychiatry Group, LLC
Lincoln, Nebraska 68510
1348
mi
from 98109
Lincoln, NE
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Clinical Study Centers, LLC
Little Rock, Arkansas 72205
1779
mi
from 98109
Little Rock, AR
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Florida Clinical Research Center LLC
Maitland, Florida 32751
2543
mi
from 98109
Maitland, FL
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Suburban Research Associates
Media, Pennsylvania 19063
2363
mi
from 98109
Media, PA
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Research Strategies
Memphis, Tennessee 38119
1876
mi
from 98109
Memphis, TN
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Clinical Trials Management
Metairie, Louisiana 70006
2091
mi
from 98109
Metairie, LA
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Middlesex Hospital
Middletown, Connecticut 06457
2437
mi
from 98109
Middletown, CT
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Clinical Research Associates
Nashville, Tennessee 37203
1971
mi
from 98109
Nashville, TN
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UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, New Jersey 08901
2388
mi
from 98109
New Brunswick, NJ
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Medical & Behavioral Health Research
New York, New York 10023
2401
mi
from 98109
New York, NY
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The Medical Research Network, LLC
New York, New York 10128
2402
mi
from 98109
New York, NY
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Eastside Comprehensive Medical Service
New York, New York 10021
2402
mi
from 98109
New York, NY
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Deaconess Clinic Gateway
Newburgh, Indiana 47630
1875
mi
from 98109
Newburgh, IN
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Pharmacology Research Institute
Newport Beach, California 92660
994
mi
from 98109
Newport Beach, CA
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Cutting Edge Research
Oklahoma City, Oklahoma 73116
1518
mi
from 98109
Oklahoma City, OK
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IPS Research
Oklahoma City, Oklahoma 73103
1522
mi
from 98109
Oklahoma City, OK
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SP Research, PLLC
Oklahoma City, Oklahoma 73112
1519
mi
from 98109
Oklahoma City, OK
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Pacific Clinical Research Medical Group
Orange, California 92868
984
mi
from 98109
Orange, CA
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Uc Irvine Medical Center
Orange, California 92868
984
mi
from 98109
Orange, CA
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CNS Healthcare
Orlando, Florida 32806
2549
mi
from 98109
Orlando, FL
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CRI Worldwide, LLC
Philadelphia, Pennsylvania 19139
2370
mi
from 98109
Philadelphia, PA
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Southwest Health Ltd
Phoenix, Arizona 85254
1108
mi
from 98109
Phoenix, AZ
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CNS Clinical Research
Pompano Beach, Florida 33067
2704
mi
from 98109
Pompano Beach, FL
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Quantum Lab. at N. Broward Memory Disorder Center
Pompano Beach, Florida 33064
2710
mi
from 98109
Pompano Beach, FL
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Oregon Center for Clinical Investigations, Inc.
Portland, Oregon 97210
146
mi
from 98109
Portland, OR
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Summit Research Network
Portland, Oregon 97210
146
mi
from 98109
Portland, OR
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Zarzar Psychiatric Associates, PLLC
Raleigh, North Carolina 27607
2358
mi
from 98109
Raleigh, NC
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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...
2352
mi
from 98109
Richmond, VA
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Rochester Center for Behavioral Medicine
Rochester Hills, Michigan 48307
1920
mi
from 98109
Rochester Hills, MI
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Northwest Behavioral Research Center
Roswell, Georgia 30076
2170
mi
from 98109
Roswell, GA
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Radiant Research
Salt Lake City, Utah 84107
706
mi
from 98109
Salt Lake City, UT
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University Of Utah Hospital
Salt Lake City, Utah 84132
702
mi
from 98109
Salt Lake City, UT
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California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California 92102
1066
mi
from 98109
San Diego, CA
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Neuropsychiatric Research Center of Orange County
Santa Ana, California 92701
987
mi
from 98109
Santa Ana, CA
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Rush University - Psychiatric Medicine Associates
Skokie, Illinois 60076
1723
mi
from 98109
Skokie, IL
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Frontier Institute
Spokane, Washington 99204
228
mi
from 98109
Spokane, WA
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Neurology Clinic of St. Cloud
St. Cloud, Minnesota 56303
1336
mi
from 98109
St. Cloud, MN
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Comprehensive NeuroScience, Inc.
St. Petersburg, Florida 33716
2522
mi
from 98109
St. Petersburg, FL
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Richmond Behavioral Associates
Staten Island, New York 10312
2399
mi
from 98109
Staten Island, NY
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Viking Clinical Research
Temecula, California 92591
1011
mi
from 98109
Temecula, CA
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BioBehavioral Health
Toms River, New Jersey 08755
2418
mi
from 98109
Toms River, NJ
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Collaborative Neuroscience Network, INC
Torrance, California 90502
976
mi
from 98109
Torrance, CA
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Brighton Research Group, LLC
Virginia Beach, Virginia 23452
2440
mi
from 98109
Virginia Beach, VA
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Coastal Research Associates
Weymouth, Massachusetts 02190
2495
mi
from 98109
Weymouth, MA
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Grayline Clinical Drug Trials
Wichita Falls, Texas 76309
1555
mi
from 98109
Wichita Falls, TX
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