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
CNS Clinical Research
Pompano Beach, Florida 33067
1295
mi
from
Pompano Beach, FL
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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,...
801
mi
from
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...
684
mi
from
Birmingham, AL
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
from
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...
1293
mi
from
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
724
mi
from
Cincinnati, OH
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Northwest Clinical Research Center
1952 - 152nd Place NE
East Seattle, Washington 98007
425-453-0404
1402
mi
from
East Seattle, WA
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MD Clinical
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
1313
mi
from
Hallandale Beach, FL
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Sunstone Medical Research, LLC
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
1355
mi
from
Medford, OR
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CRI Worldwide
16000 Horizon Way Mount
Mt Laurel, New Jersey 08054
856-533-5020
1236
mi
from
Mt Laurel, NJ
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Alliance Research Group
3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
1110
mi
from
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...
1340
mi
from
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...
1320
mi
from
South Miami, FL
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InSite Clinical Research
941 York Drive DeSoto
Southwest, Texas 75115
214-477-5162
356
mi
from
Southwest, TX
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Janus Center for Psychiatric Research
5601 Corporate Way
West Palm Beach, Florida 33407
561-238-3036
1280
mi
from
West Palm Beach, FL
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Albuquerque Neuroscience Inc.
Albuquerque, New Mexico 87109
517
mi
from
Albuquerque, NM
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Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
1207
mi
from
Allentown, PA
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ICSL Clinical Studies
Altamonte Springs, Florida 32701
1136
mi
from
Altamonte Springs, FL
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Millwood Hospital
Arlington, Texas 76011
347
mi
from
Arlington, TX
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Pharmasite Research
Baltimore, Maryland 21208
1142
mi
from
Baltimore, MD
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Sheppard Pratt Health System
Baltimore, Maryland 21285
1149
mi
from
Baltimore, MD
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Southwestern Research Institute
Beverly Hills, California 90210
1176
mi
from
Beverly Hills, CA
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Boston Clinical Trials, INC.
Boston, Massachusetts 02135
1444
mi
from
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...
436
mi
from
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,...
1134
mi
from
Bradenton, FL
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Social Psychiatric Research Institute
Brooklyn, New York 11235
1289
mi
from
Brooklyn, NY
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Neuro-Behavioral Cilnical Research Inc
Canton, Ohio 44718
900
mi
from
Canton, OH
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Neurobehavioral Research, Inc.
Cedarhurst, New York 11516
1301
mi
from
Cedarhurst, NY
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Comprehensive NeuroScience
Cerritos, California 90703
1163
mi
from
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...
1063
mi
from
Charleston, SC
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Metro Health Medical Center
Cleveland, Ohio 44109
893
mi
from
Cleveland, OH
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North Star Medical Research
Cleveland, Ohio 44130
888
mi
from
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...
810
mi
from
Columbus, OH
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Arocha Research Center
Coral Gables, Florida 33134
1318
mi
from
Coral Gables, FL
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ATP Clinical Research, Inc.
Costa Mesa, California 92626
1158
mi
from
Costa Mesa, CA
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FutureSearch Clinical Trials, LP
Dallas, Texas 75231
342
mi
from
Dallas, TX
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Western Affiliated Research Institute
Denver, Colorado 80204
411
mi
from
Denver, CO
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Michigan State University
East Lansing, Michigan 48824
781
mi
from
East Lansing, MI
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Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois 60007
597
mi
from
Elk Grove Village, IL
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Odyssey Research Services
Fargo, North Dakota 58104
628
mi
from
Fargo, ND
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SJS Clinical Research
Fort Walton Beach, Florida 32547
814
mi
from
Fort Walton Beach, FL
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Psychiatric Consultants
Franklin, Tennessee 37067
622
mi
from
Franklin, TN
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Collaborative Neuroscience Network
Garden Grove, California 92845
1162
mi
from
Garden Grove, CA
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Advanced Research Associates
Glendale, Arizona 85308
852
mi
from
Glendale, AZ
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Pine Rest Christian Mental Health Services
Grand rapids, Michigan 49548
730
mi
from
Grand rapids, MI
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Pharmquest
Greensboro, North Carolina 27408
999
mi
from
Greensboro, NC
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Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois 60169
593
mi
from
Hoffman Estates, IL
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Hawaii Clinical Research Center
Honolulu, Hawaii 96813
3717
mi
from
Honolulu, HI
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Claghorn-Lesem Research Clinic
Houston, Texas 77008
566
mi
from
Houston, TX
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Bayou City Research Limited
Houston, Texas 77007
568
mi
from
Houston, TX
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Goldpoint Clinical Research
Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
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Clinical Neuroscience Solution, Inc.
Jacksonville, Florida 32216
1061
mi
from
Jacksonville, FL
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Joliet Center for Clinical Research
Joliet, Illinois 60435
578
mi
from
Joliet, IL
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Dynamic Clinical Research, Inc.
Kansas City, Missouri 64114
193
mi
from
Kansas City, MO
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Independent Clinical Researchers
Las Vegas, Nevada 89106
961
mi
from
Las Vegas, NV
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Capstone Clinical Research
Libertyville, Illinois 60048
608
mi
from
Libertyville, IL
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Premier Psychiatry Group, LLC
Lincoln, Nebraska 68510
220
mi
from
Lincoln, NE
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Clinical Study Centers, LLC
Little Rock, Arkansas 72205
369
mi
from
Little Rock, AR
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Florida Clinical Research Center LLC
Maitland, Florida 32751
1138
mi
from
Maitland, FL
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Suburban Research Associates
Media, Pennsylvania 19063
1212
mi
from
Media, PA
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Research Strategies
Memphis, Tennessee 38119
479
mi
from
Memphis, TN
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Clinical Trials Management
Metairie, Louisiana 70006
690
mi
from
Metairie, LA
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Middlesex Hospital
Middletown, Connecticut 06457
1359
mi
from
Middletown, CT
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Clinical Research Associates
Nashville, Tennessee 37203
618
mi
from
Nashville, TN
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UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, New Jersey 08901
1263
mi
from
New Brunswick, NJ
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Medical & Behavioral Health Research
New York, New York 10023
1288
mi
from
New York, NY
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The Medical Research Network, LLC
New York, New York 10128
1289
mi
from
New York, NY
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Eastside Comprehensive Medical Service
New York, New York 10021
1289
mi
from
New York, NY
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Deaconess Clinic Gateway
Newburgh, Indiana 47630
569
mi
from
Newburgh, IN
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Pharmacology Research Institute
Newport Beach, California 92660
1158
mi
from
Newport Beach, CA
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Cutting Edge Research
Oklahoma City, Oklahoma 73116
153
mi
from
Oklahoma City, OK
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IPS Research
Oklahoma City, Oklahoma 73103
157
mi
from
Oklahoma City, OK
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Red River Medical Research
Oklahoma City, Oklahoma 73112
154
mi
from
Oklahoma City, OK
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SP Research, PLLC
Oklahoma City, Oklahoma 73112
154
mi
from
Oklahoma City, OK
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Pacific Clinical Research Medical Group
Orange, California 92868
1154
mi
from
Orange, CA
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Uc Irvine Medical Center
Orange, California 92868
1154
mi
from
Orange, CA
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CNS Healthcare
Orlando, Florida 32806
1143
mi
from
Orlando, FL
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CRI Worldwide, LLC
Philadelphia, Pennsylvania 19139
1221
mi
from
Philadelphia, PA
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Southwest Health Ltd
Phoenix, Arizona 85254
841
mi
from
Phoenix, AZ
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Quantum Lab. at N. Broward Memory Disorder Center
Pompano Beach, Florida 33064
1301
mi
from
Pompano Beach, FL
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Oregon Center for Clinical Investigations, Inc.
Portland, Oregon 97210
1385
mi
from
Portland, OR
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Summit Research Network
Portland, Oregon 97210
1385
mi
from
Portland, OR
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Zarzar Psychiatric Associates, PLLC
Raleigh, North Carolina 27607
1064
mi
from
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...
1113
mi
from
Richmond, VA
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Rochester Center for Behavioral Medicine
Rochester Hills, Michigan 48307
844
mi
from
Rochester Hills, MI
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Northwest Behavioral Research Center
Roswell, Georgia 30076
797
mi
from
Roswell, GA
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Radiant Research
Salt Lake City, Utah 84107
778
mi
from
Salt Lake City, UT
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University Of Utah Hospital
Salt Lake City, Utah 84132
777
mi
from
Salt Lake City, UT
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California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California 92102
1141
mi
from
San Diego, CA
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Neuropsychiatric Research Center of Orange County
Santa Ana, California 92701
1154
mi
from
Santa Ana, CA
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Rush University - Psychiatric Medicine Associates
Skokie, Illinois 60076
610
mi
from
Skokie, IL
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Frontier Institute
Spokane, Washington 99204
1202
mi
from
Spokane, WA
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Neurology Clinic of St. Cloud
St. Cloud, Minnesota 56303
571
mi
from
St. Cloud, MN
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Comprehensive NeuroScience, Inc.
St. Petersburg, Florida 33716
1112
mi
from
St. Petersburg, FL
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Richmond Behavioral Associates
Staten Island, New York 10312
1277
mi
from
Staten Island, NY
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Viking Clinical Research
Temecula, California 92591
1119
mi
from
Temecula, CA
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BioBehavioral Health
Toms River, New Jersey 08755
1276
mi
from
Toms River, NJ
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Collaborative Neuroscience Network, INC
Torrance, California 90502
1176
mi
from
Torrance, CA
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Brighton Research Group, LLC
Virginia Beach, Virginia 23452
1193
mi
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Virginia Beach, VA
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Coastal Research Associates
Weymouth, Massachusetts 02190
1449
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Weymouth, MA
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Grayline Clinical Drug Trials
Wichita Falls, Texas 76309
269
mi
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Wichita Falls, TX
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