Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
- Registration Number
- NCT01156415
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 837
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Agomelatine (AGO178) 0.5 mg AGO178 - Agomelatine (AGO178) 1 mg AGO178 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (97)
Emory University
🇺🇸Atlanta, Georgia, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
ATP Clinical Research, Inc
🇺🇸Costa Mesa, California, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
CRI Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Pharmquest
🇺🇸Greensboro, North Carolina, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Independent Psychiatric Consultants
🇺🇸Waukesha, Wisconsin, United States
Comprehensive Neuroscience
🇺🇸Cerritos, California, United States
North Star Medical Research
🇺🇸Cleveland, Ohio, United States
The Ohio State Universtiy - Harding Hospital
🇺🇸Columbus, Ohio, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
University of California, San Diego Medical Center
🇺🇸San Diego, California, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Bayou City Research Limited
🇺🇸Houston, Texas, United States
Claghorn Lesem Research Clinic, Inc.
🇺🇸Houston, Texas, United States
Texas Center for Drug Development
🇺🇸Houston, Texas, United States
Odyssey Research Services
🇺🇸Fargo, North Dakota, United States
Hawaii Clinical Research Center
🇺🇸Honolulu, Hawaii, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
University of Utah Mood Disorders Clinic
🇺🇸Salt Lake City, Utah, United States
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
SP Research
🇺🇸Oklahoma City, Oklahoma, United States
Cutting Edge Research
🇺🇸Oklahoma City, Oklahoma, United States
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
INSPIRA Clinical Research
🇵🇷San Juan, Puerto Rico
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Clinical Study Centers, LLC
🇺🇸Little Rock, Arkansas, United States
Southwest Health Ltd dba The Mollen Clinic
🇺🇸Scottsdale, Arizona, United States
Research Strategies of Memphis
🇺🇸Memphis, Tennessee, United States
Robert Wood Johnson Medical School
🇺🇸Piscataway, New Jersey, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Western Affiliated Research Institute
🇺🇸Denver, Colorado, United States
Oregon Center for Clinical Investigations
🇺🇸Portland, Oregon, United States
Summit Research
🇺🇸Portland, Oregon, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Southwestern Research Institute
🇺🇸Beverly Hills, California, United States
Collaborative Neuroscience Network
🇺🇸Garden Grove, California, United States
Pacific Clinical Research Medical Group
🇺🇸Orange, California, United States
CNRI-San Diego, LLC
🇺🇸San Diego, California, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Santa Ana, California, United States
Viking Clinical Research Center
🇺🇸Temecula, California, United States
Clinical Studies
🇺🇸Altamonte Springs, Florida, United States
Collaborative Neuroscience
🇺🇸Torrance, California, United States
Middlesex Hospital
🇺🇸Middletown, Connecticut, United States
Arocha Research Center
🇺🇸Coral Gables, Florida, United States
Sjs Clinical Research
🇺🇸Destin, Florida, United States
CNS Clinical Research
🇺🇸Coral Springs, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Florida Clinical Research Center
🇺🇸Maitland, Florida, United States
Comprehensive NeuroScience, Inc.
🇺🇸Saint Petersburg, Florida, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Quantum Lab. at N. Broward Memory Disorder Center
🇺🇸Pompano Beach, Florida, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Joliet Center for Clinical Research
🇺🇸Joliet, Illinois, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Rush University Medical Center
🇺🇸Skokie, Illinois, United States
Deaconess Clinic Gateway
🇺🇸Newburgh, Indiana, United States
Pharmasite Research
🇺🇸Pikesville, Maryland, United States
Mount Auburn Medical Associates
🇺🇸Watertown, Massachusetts, United States
Pine Rest Christian Mental Health Services
🇺🇸Grand Rapids, Michigan, United States
Coastal Research Associates
🇺🇸Weymouth, Massachusetts, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Rochester Center for Behavioral Medicine
🇺🇸Rochester Hills, Michigan, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
CRI Worldwide
🇺🇸Willingboro, New Jersey, United States
Neurological Associates Of Albany
🇺🇸Albany, New York, United States
Comprehensive Psychiatric Associates
🇺🇸Gladstone, Missouri, United States
Albuquerque Neuroscience
🇺🇸Albuquerque, New Mexico, United States
Eastside Comprehensive Medical Service
🇺🇸New York, New York, United States
Medical & Behavior Health Research
🇺🇸New York, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Zarzar Psychiatric Associates
🇺🇸Raleigh, North Carolina, United States
Neuro Behavioral Clinical Research
🇺🇸Canton, Ohio, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Neurology & Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Millwood Hospital
🇺🇸Arlington, Texas, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Alliance Research Group, LLC
🇺🇸Richmond, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Frontier Institute
🇺🇸Spokane, Washington, United States
Centro de Investigacion Clinica Psiquiatrica
🇵🇷Ponce, Puerto Rico
Dharma Institute and Research Center
🇵🇷San Juan, Puerto Rico
Social Psychiatry Research, Inc./ SPRI
🇺🇸Brooklyn, New York, United States
CNS Healthcare
🇺🇸Orlando, Florida, United States
Piedmont Medical Research Associates, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Radiant Research
🇺🇸Salt Lake City, Utah, United States