Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
A 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
589
2 countries
45
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
Started May 2010
Shorter than P25 for phase_3 major-depressive-disorder
45 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
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 24, 2020
September 1, 2012
1.1 years
April 23, 2010
December 16, 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 (45)
University of Alabama at Birmingham, Department of Psychiatry
Birmingham, Alabama, 35294, United States
ATP Clinical Research
Costa Mesa, California, 92626, United States
Valley Clinical Research
El Centro, California, 92243, United States
Collaborative Neuroscience Network
Garden Grove, California, 92845, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Affiliated Research Institute
San Diego, California, 92108, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Viking Clinical Research
Temecula, California, 92591, United States
ICSL 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
Innova Clinical Trials
Miami, Florida, 33145, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Emory University
Atlanta, Georgia, 30306, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Joliet Center for Clinical Research
Joliet, Illinois, 60435, United States
CNS Clinical Trials
Park Ridge, Illinois, 60068, United States
Deaconess Clinic
Evansville, Indiana, 47713, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Pharmasite Research
Pikesville, Maryland, 21208, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Clinical Trials
Brighton, Massachusetts, 02135, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Premier Psychiatry Group, LLC
Lincoln, Nebraska, 68510, United States
CRI Worldwide, LLC - Lourdes Division
Willingboro, New Jersey, 08046, United States
Social Psychiatric Research Institute
Brooklyn, New York, 11235, United States
Eastside Comprehensive Medical Service
New York, New York, 10021, United States
Neurobehavioral Clinical Research
Canton, Ohio, 44718, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
SP Research
Oklahoma City, Oklahoma, 73112, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Summit Research Network
Portland, Oregon, 97210, United States
CRI Worldwide, LLC - Kirkbride Division
Philadelphia, Pennsylvania, 19139, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
CNS Healthcare
Memphis, Tennessee, 38119, United States
Research Strategies
Memphis, Tennessee, 38119, United States
FutureSearch Trials
Austin, Texas, 78731, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, 77008, United States
University of Utah, Department of Psychiatry
Salt Lake City, Utah, 84132, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Summit Research
Seattle, Washington, 98104, United States
Caribbean Research and Education Center
Bayamón, 00959, Puerto Rico
Dharma Institute and Research Center
San Juan, 00907, 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
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 24, 2020
Record last verified: 2012-09