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

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ClinicalTrials.gov Identifier: NCT01156415
Recruitment Status : Terminated
First Posted : July 2, 2010
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: AGO178 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 837 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)
Study Start Date : June 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Agomelatine (AGO178) 0.5 mg Drug: AGO178
Experimental: Agomelatine (AGO178) 1 mg Drug: AGO178



Primary Outcome Measures :
  1. Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale [ Time Frame: Week 6, 8, 12, 28, 36 and 52 ]
  2. Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scale [ Time Frame: Week 6, 8, 12, 28, 36 and 52 ]
  3. Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52 [ Time Frame: Week 52 ]
  4. Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52 [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Key Inclusion Criteria Cohort I:

  • Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
  • Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).
  • Female patients should continue to use effective contraception as defined in double-blind study protocol.

Inclusion Criteria:

Key Inclusion criteria Cohort II:

  • Male and female adults, 18 through 70 years of age, inclusive.
  • Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
  • Current episode ≥4 weeks.
  • CGI-Severity score ≥4 at Screening and Baseline.

Exclusion Criteria:

Key Exclusion Criteria Cohort I:

  • Concomitant use of fluvoxamine.
  • Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.

Exclusion Criteria:

Key Exclusion criteria Cohort II:

  • History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
  • 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.
  • Prior exposure to agomelatine.
  • Female patients of childbearing potential who are not using effective contraception.

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156415


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Advanced Research Associates
Glendale, Arizona, United States, 85308
Southwest Health Ltd dba The Mollen Clinic
Scottsdale, Arizona, United States, 85254
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Southwestern Research Institute
Beverly Hills, California, United States, 90210
Comprehensive Neuroscience
Cerritos, California, United States, 90703
ATP Clinical Research, Inc
Costa Mesa, California, United States, 92626
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Pacific Clinical Research Medical Group
Orange, California, United States, 92868
CNRI-San Diego, LLC
San Diego, California, United States, 92102
University of California, San Diego Medical Center
San Diego, California, United States, 92103
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92701
Viking Clinical Research Center
Temecula, California, United States, 92591
Collaborative Neuroscience
Torrance, California, United States, 90502
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Western Affiliated Research Institute
Denver, Colorado, United States, 80209
United States, Connecticut
Middlesex Hospital
Middletown, Connecticut, United States, 06457
United States, Florida
Clinical Studies
Altamonte Springs, Florida, United States, 32701
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34208
Arocha Research Center
Coral Gables, Florida, United States, 33134
CNS Clinical Research
Coral Springs, Florida, United States, 33067
Sjs Clinical Research
Destin, Florida, United States, 32541
MD Clinical
Hallandale Beach, Florida, United States, 33009
CNS Healthcare
Jacksonville, Florida, United States, 32216
Florida Clinical Research Center
Maitland, Florida, United States, 34201
CNS Healthcare
Orlando, Florida, United States, 32806
Quantum Lab. at N. Broward Memory Disorder Center
Pompano Beach, Florida, United States, 33064
Miami Research Associates
South Miami, Florida, United States, 33143
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States, 33716
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
United States, Hawaii
Hawaii Clinical Research Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States, 60169
Joliet Center for Clinical Research
Joliet, Illinois, United States, 60435
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
Rush University Medical Center
Skokie, Illinois, United States, 60076
United States, Indiana
Deaconess Clinic Gateway
Newburgh, Indiana, United States, 47630
United States, Maryland
Pharmasite Research
Pikesville, Maryland, United States, 21208
United States, Massachusetts
Boston Clinical Trials
Boston, Massachusetts, United States, 02135
Mount Auburn Medical Associates
Watertown, Massachusetts, United States, 02472
Coastal Research Associates
Weymouth, Massachusetts, United States, 02190
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Pine Rest Christian Mental Health Services
Grand rapids, Michigan, United States, 49548
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States, 48307
United States, Missouri
Comprehensive Psychiatric Associates
Gladstone, Missouri, United States, 64118
United States, New Jersey
Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
CRI Worldwide
Willingboro, New Jersey, United States, 08046
United States, New Mexico
Albuquerque Neuroscience
Albuquerque, New Mexico, United States, 87109
United States, New York
Neurological Associates Of Albany
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467
Social Psychiatry Research, Inc./ SPRI
Brooklyn, New York, United States, 11235
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11516
Eastside Comprehensive Medical Service
New York, New York, United States, 10021
Medical & Behavior Health Research
New York, New York, United States, 10023
The Medical Research Network, LLC
New York, New York, United States, 10128
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
Pharmquest
Greensboro, North Carolina, United States, 27408
Zarzar Psychiatric Associates
Raleigh, North Carolina, United States, 27607
Piedmont Medical Research Associates, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Odyssey Research Services
Fargo, North Dakota, United States, 58104
United States, Ohio
Neuro Behavioral Clinical Research
Canton, Ohio, United States, 44718
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
North Star Medical Research
Cleveland, Ohio, United States, 44130
The Ohio State Universtiy - Harding Hospital
Columbus, Ohio, United States, 43210
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
SP Research
Oklahoma City, Oklahoma, United States, 73112
Cutting Edge Research
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
Sunstone Medical Research, LLC
Medford, Oregon, United States, 97504
Oregon Center for Clinical Investigations
Portland, Oregon, United States, 97210
Summit Research
Portland, Oregon, United States, 97210
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Suburban Research Associates
Media, Pennsylvania, United States, 19063
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29406
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
Research Strategies of Memphis
Memphis, Tennessee, United States, 38119
Clinical Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Millwood Hospital
Arlington, Texas, United States, 76011
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
InSite Clinical Research
DeSoto, Texas, United States, 75115
Bayou City Research Limited
Houston, Texas, United States, 77007
Claghorn Lesem Research Clinic, Inc.
Houston, Texas, United States, 77008
Texas Center for Drug Development
Houston, Texas, United States, 77081
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
United States, Utah
Radiant Research
Salt Lake City, Utah, United States, 84107
University of Utah Mood Disorders Clinic
Salt Lake City, Utah, United States, 84132
United States, Virginia
Alliance Research Group, LLC
Richmond, Virginia, United States, 23230
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Frontier Institute
Spokane, Washington, United States, 99204
United States, Wisconsin
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States, 53188
Puerto Rico
Centro de Investigacion Clinica Psiquiatrica
Ponce, Puerto Rico, 00731
Dharma Institute and Research Center
San Juan, Puerto Rico, 00907
INSPIRA Clinical Research
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01156415     History of Changes
Other Study ID Numbers: CAGO178C2399
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
agomelatine
Major Depressive Disorder
MDD
depression
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Depression
Pathologic Processes
Behavioral Symptoms
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs