Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)
1 other identifier
interventional
582
2 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 major-depressive-disorder
48 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
First Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedDecember 23, 2020
February 1, 2013
1.2 years
April 23, 2010
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Baseline and 8 weeks
Secondary Outcomes (5)
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
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
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
Study Arms (3)
AGO178C 0.5 mg /day
EXPERIMENTALAGO178C 1 mg / day
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Birmingham Psychiatry
Birmingham, Alabama, 25226, United States
Southwestern Research Institute
Beverly Hills, California, 90210, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Mood & Anxiety Research
Fresno, California, 93720, United States
Excell Research, Inc
Oceanside, California, 92056, United States
Cnri-La, Llc
Pico Rivera, California, 90660, United States
CNRI San Diego
San Diego, California, 92102, United States
University of California San Diego Medical Center
San Diego, California, 92103, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Western Affiliated Research Institute
Denver, Colorado, 80204, United States
Clinical Research Institute of South Florida
Hialeah, Florida, 33013, United States
Florida Clinical Research Center LLC
Maitland, Florida, 32751, United States
CNS Healthcare
Orlando, Florida, 32806, United States
Broward Research Group
Pembroke Pines, Florida, 33026, United States
Quantum Lab. N. Broward Memory Disorder Center
Pompano Beach, Florida, 33064, 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
Mountain West Clinical Trials
Eagle, Idaho, 83616, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
CTT Clinical Trials Technology
Prairie Village, Kansas, 66206, United States
Clinical Trials Management
Metairie, Louisiana, 70006, United States
Mount Auburn Medical Associates
Watertown, Massachusetts, 02472, United States
Coastal Research Associates
Weymouth, Massachusetts, 02190, United States
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64114, United States
Psychopharmacology Research Association of Princeton
Princeton, New Jersey, 08540, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109, United States
Neurological Associates Of Albany, P.C.
Albany, New York, 12208, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Odyssey Research Services
Fargo, North Dakota, 58104, United States
The Ohio State University - Harding Hospital
Columbus, Ohio, 43210, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116, United States
Sunstone Medical Research, LLC
Medford, Oregon, 97504, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Psychiatric Consultants
Franklin, Tennessee, 37067, United States
KRK Medical Research
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Texas Center for Drug Development
Houston, Texas, 77081, United States
Alliance Research Group, LLC
Richmond, Virginia, 23230, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 27, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2011
Last Updated
December 23, 2020
Record last verified: 2013-02