Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT01110902
- 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
- 589
- 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 AGO178C 0.5 mg /day Agomelatine (AGO178C) - AGO178C 1 mg / day Agomelatine (AGO178C) - Placebo Placebo -
- 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 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 Proportion of patients who achieve remission 8 weeks 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 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 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
Trial Locations
- Locations (45)
CRI Worldwide, LLC - Lourdes Division
🇺🇸Willingboro, New Jersey, United States
Medical University of South Carolina
🇺🇸North Charleston, South Carolina, United States
SP Research
🇺🇸Oklahoma City, Oklahoma, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Claghorn-Lesem Research Clinic, Inc.
🇺🇸Houston, Texas, United States
University of Alabama at Birmingham, Department of Psychiatry
🇺🇸Birmingham, Alabama, United States
Deaconess Clinic
🇺🇸Evansville, Indiana, United States
CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Collaborative Neuroscience Network
🇺🇸Garden Grove, California, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Research Strategies
🇺🇸Memphis, Tennessee, United States
Eastside Comprehensive Medical Service
🇺🇸New York, New York, United States
Neurology & Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Neurobehavioral Clinical Research
🇺🇸Canton, Ohio, United States
Social Psychiatric Research Institute
🇺🇸Brooklyn, New York, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Valley Clinical Research
🇺🇸El Centro, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Arocha Research Center
🇺🇸Coral Gables, Florida, United States
ICSL Clinical Studies
🇺🇸Altamonte Springs, Florida, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Innova Clinical Trials
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Joliet Center for Clinical Research
🇺🇸Joliet, Illinois, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Pharmasite Research
🇺🇸Pikesville, Maryland, United States
Boston Clinical Trials
🇺🇸Brighton, Massachusetts, United States
Mercy Health Research
🇺🇸Saint Louis, Missouri, United States
Premier Psychiatry Group, LLC
🇺🇸Lincoln, Nebraska, United States
CRI Worldwide, LLC - Kirkbride Division
🇺🇸Philadelphia, Pennsylvania, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
University of Utah, Department of Psychiatry
🇺🇸Salt Lake City, Utah, United States
Summit Research
🇺🇸Seattle, Washington, United States
Caribbean Research and Education Center
🇵🇷Bayamon, Puerto Rico
Dharma Institute and Research Center
🇵🇷San Juan, Puerto Rico
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
CNS Clinical Trials
🇺🇸Park Ridge, Illinois, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States