Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)
1 other identifier
interventional
508
2 countries
44
Brief Summary
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label 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
44 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
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 11, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedDecember 23, 2020
May 1, 2012
1.1 years
December 11, 2006
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
8 weeks
Secondary Outcomes (5)
To evaluate the 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
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
8 weeks
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
8 weeks
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17
8 weeks
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8
8 weeks
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
- HAM-D17 total score \> or = 22 at Screening and Baseline
- CGI-Severity score \> or = 4 at Screening and Baseline
- Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase
You may not qualify if:
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
- Any current Axis I disorder other than major depressive disorder 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
- Female patients of childbearing potential who are not using effective contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (44)
Novartis Investigative Site
Scottsdale, Arizona, 85251, United States
Novartis Investigative Site
Little Rock, Arkansas, 72205, United States
Novartis Investigative Site
Cerritos, California, 90703, United States
Novartis Investigative Site
El Centro, California, 92243, United States
Novartis Investigative Site
Garden Grove, California, 92845, United States
Novartis Investigative Site
Irvine, California, 92618, United States
Novartis Investigative Site
Lafayette, California, 94549, United States
Novartis Investigative Site
San Diego, California, 92126, United States
Novartis Investigative Site
Temecula, California, 92591, United States
Novartis Investigative Site
Cromwell, Connecticut, 06416, United States
Novartis Investigative Site
Hamden, Connecticut, 06518, United States
Novartis Investigative Site
Bradenton, Florida, 34208, United States
Novartis Investigative Site
Jacksonville, Florida, 32216, United States
Novartis Investigative Site
Maitland, Florida, 32751, United States
Novartis Investigative Site
Port Charlotte, Florida, 33952, United States
Novartis Investigative Site
Atlanta, Georgia, 30308, United States
Novartis Investigative Site
Atlanta, Georgia, 30329, United States
Novartis Investigative Site
Marietta, Georgia, 30060, United States
Novartis Investigative Site
Overland Park, Kansas, 66212, United States
Novartis Investigative Site
Rockville, Maryland, 20852, United States
Novartis Investigative Site
Salisbury, Maryland, 21801, United States
Novartis Investigative Site
Pittsfield, Massachusetts, 01201, United States
Novartis Investigative Site
Farmington Hills, Michigan, 48336, United States
Novartis Investigative Site
Rochester Hills, Michigan, 48307, United States
Novartis Investigative Site
City of Saint Peters, Missouri, 63376, United States
Novartis Investigative Site
Princeton, New Jersey, 08540, United States
Novartis Investigative Site
Albuquerque, New Mexico, 87102, United States
Novartis Investigative Site
Brooklyn, New York, 11235, United States
Novartis Investigative Site
New York, New York, 10021, United States
Novartis Investigative Site
Beachwood, Ohio, 44122, United States
Novartis Investigative Site
Dayton, Ohio, 45408, United States
Novartis Investigative Site
Tulsa, Oklahoma, 74136, United States
Novartis Investigative Site
Eugene, Oregon, 97404, United States
Novartis Investigative Site
North Charleston, South Carolina, 29406, United States
Novartis Investigative Site
Nashville, Tennessee, 37203, United States
Novartis Investigative Site
Austin, Texas, 78754, United States
Novartis Investigative Site
Dallas, Texas, 75231, United States
Novartis Investigative Site
Houston, Texas, 77007, United States
Novartis Investigative Site
Salt Lake City, Utah, 84107, United States
Novartis Investigative Site
Bennington, Vermont, 05201, United States
Novartis Investigative Site
Midlothian, Virginia, 23112, United States
Novartis Investigative Site
Bothell, Washington, 98011, United States
Novartis Investigative Site
Bayamón, 00959, Puerto Rico
Novartis Investigative Site
Rio Piedras, 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
December 11, 2006
First Posted
December 13, 2006
Study Start
December 1, 2006
Primary Completion
January 1, 2008
Last Updated
December 23, 2020
Record last verified: 2012-05