Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)
1 other identifier
interventional
837
2 countries
98
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
Started Jun 2010
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 30, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedDecember 24, 2020
March 1, 2013
1.3 years
June 30, 2010
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale
52 weeks
Secondary Outcomes (4)
Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale
Week 6, 8, 12, 28, 36 and 52
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
Week 6, 8, 12, 28, 36 and 52
Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52
Week 52
Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52
Week 52
Study Arms (2)
Agomelatine (AGO178) 0.5 mg
EXPERIMENTALAgomelatine (AGO178) 1 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Advanced Research Associates
Glendale, Arizona, 85308, United States
Southwest Health Ltd dba The Mollen Clinic
Scottsdale, Arizona, 85254, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
Southwestern Research Institute
Beverly Hills, California, 90210, United States
Comprehensive Neuroscience
Cerritos, California, 90703, United States
ATP Clinical Research, Inc
Costa Mesa, California, 92626, United States
Collaborative Neuroscience Network
Garden Grove, California, 92845, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
CNRI-San Diego, LLC
San Diego, California, 92102, United States
University of California, San Diego Medical Center
San Diego, California, 92103, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701, United States
Viking Clinical Research Center
Temecula, California, 92591, United States
Collaborative Neuroscience
Torrance, California, 90502, United States
University of Colorado
Aurora, Colorado, 80045, United States
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
Clinical Studies
Altamonte Springs, Florida, 32701, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208, United States
Arocha Research Center
Coral Gables, Florida, 33134, United States
CNS Clinical Research
Coral Springs, Florida, 33067, United States
Sjs Clinical Research
Destin, Florida, 32541, United States
MD Clinical
Hallandale, Florida, 33009, United States
CNS Healthcare
Jacksonville, Florida, 32216, United States
Florida Clinical Research Center
Maitland, Florida, 34201, United States
CNS Healthcare
Orlando, Florida, 32806, United States
Quantum Lab. at N. Broward Memory Disorder Center
Pompano Beach, Florida, 33064, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Emory University
Atlanta, Georgia, 30306, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, 96813, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Joliet Center for Clinical Research
Joliet, Illinois, 60435, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Rush University Medical Center
Skokie, Illinois, 60076, United States
Deaconess Clinic Gateway
Newburgh, Indiana, 47630, United States
Pharmasite Research
Pikesville, Maryland, 21208, United States
Boston Clinical Trials
Boston, Massachusetts, 02135, United States
Mount Auburn Medical Associates
Watertown, Massachusetts, 02472, United States
Coastal Research Associates
Weymouth, Massachusetts, 02190, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64118, United States
Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
CRI Worldwide
Willingboro, New Jersey, 08046, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109, United States
Neurological Associates Of Albany
Albany, New York, 12208, United States
Social Psychiatry Research, Inc./ SPRI
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Eastside Comprehensive Medical Service
New York, New York, 10021, United States
Medical & Behavior Health Research
New York, New York, 10023, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
Zarzar Psychiatric Associates
Raleigh, North Carolina, 27607, United States
Piedmont Medical Research Associates, Inc.
Winston-Salem, North Carolina, 27103, United States
Odyssey Research Services
Fargo, North Dakota, 58104, United States
Neuro Behavioral Clinical Research
Canton, Ohio, 44718, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
North Star Medical Research
Cleveland, Ohio, 44130, United States
The Ohio State Universtiy - Harding Hospital
Columbus, Ohio, 43210, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
SP Research
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116, United States
Sunstone Medical Research, LLC
Medford, Oregon, 97504, United States
Oregon Center for Clinical Investigations
Portland, Oregon, 97210, United States
Summit Research
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Medical University of South Carolina
Charleston, South Carolina, 29406, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Research Strategies of Memphis
Memphis, Tennessee, 38119, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Millwood Hospital
Arlington, Texas, 76011, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Bayou City Research Limited
Houston, Texas, 77007, United States
Claghorn Lesem Research Clinic, Inc.
Houston, Texas, 77008, United States
Texas Center for Drug Development
Houston, Texas, 77081, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Radiant Research
Salt Lake City, Utah, 84107, United States
University of Utah Mood Disorders Clinic
Salt Lake City, Utah, 84132, United States
Alliance Research Group, LLC
Richmond, Virginia, 23230, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Frontier Institute
Spokane, Washington, 99204, United States
Independent Psychiatric Consultants
Waukesha, Wisconsin, 53188, United States
Centro de Investigacion Clinica Psiquiatrica
Ponce, 00731, Puerto Rico
Dharma Institute and Research Center
San Juan, 00907, Puerto Rico
INSPIRA Clinical Research
San Juan, 00918, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2010
First Posted
July 2, 2010
Study Start
June 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
December 24, 2020
Record last verified: 2013-03