Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT01110889
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The study will assess efficacy, 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. This study includes an 8-week double-blind phase.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 582
- Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
- Current episode ≥4 weeks.
- CGI-Severity score ≥4 at Screening and Baseline.
- 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.
- Concomitant psychotropic medication, including herbal preparations and melatonin.
- Psychotherapy of any type.
- 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 Placebo Placebo - AGO178C 1 mg / day Agomelatine (AGO178C) - AGO178C 0.5 mg /day Agomelatine (AGO178C) -
- Primary Outcome Measures
Name Time Method Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale Baseline and 8 weeks
- Secondary Outcome Measures
Name Time Method Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8 8 weeks Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale 8 weeks Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale. 8 weeks Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint 8 weeks Proportion of patients who achieve remission 8 weeks
Trial Locations
- Locations (48)
The Ohio State University - Harding Hospital
🇺🇸Columbus, Ohio, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Clinical Trials Management
🇺🇸Metairie, Louisiana, United States
Inspira Clinical Research
🇵🇷San Juan, Puerto Rico
CNRI San Diego
🇺🇸San Diego, California, United States
Texas Center for Drug Development
🇺🇸Houston, Texas, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Western Affiliated Research Institute
🇺🇸Denver, Colorado, United States
Birmingham Psychiatry
🇺🇸Birmingham, Alabama, United States
Southwestern Research Institute
🇺🇸Beverly Hills, California, United States
Pharmacology Research Institute
🇺🇸Encino, California, United States
Mood & Anxiety Research
🇺🇸Fresno, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
Cnri-La, Llc
🇺🇸Pico Rivera, California, United States
Clinical Research Institute of South Florida
🇺🇸Hialeah, Florida, United States
Florida Clinical Research Center LLC
🇺🇸Maitland, Florida, United States
Broward Research Group
🇺🇸Pembroke Pines, Florida, United States
Quantum Lab. N. Broward Memory Disorder Center
🇺🇸Pompano Beach, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Mountain West Clinical Trials
🇺🇸Eagle, Idaho, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
CTT Clinical Trials Technology
🇺🇸Prairie Village, Kansas, United States
Coastal Research Associates
🇺🇸Weymouth, Massachusetts, United States
Mount Auburn Medical Associates
🇺🇸Watertown, Massachusetts, United States
Comprehensive Psychiatric Associates
🇺🇸Gladstone, Missouri, United States
Psychopharmacology Research Association of Princeton
🇺🇸Princeton, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Neurological Associates Of Albany, P.C.
🇺🇸Albany, New York, United States
Neurobehavioral Research Inc.
🇺🇸Cedarhurst, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Odyssey Research Services
🇺🇸Fargo, North Dakota, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
Cutting Edge Research
🇺🇸Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Psychiatric Consultants
🇺🇸Franklin, Tennessee, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Alliance Research Group, LLC
🇺🇸Richmond, Virginia, United States
CNS Healthcare
🇺🇸Orlando, Florida, United States
Hawaii Clinical Research Center
🇺🇸Honolulu, Hawaii, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Albuquerque Neuroscience
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States