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 (CAGO178A2302E)
1 other identifier
interventional
503
1 country
51
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
51 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)
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 (51)
Novartis Investigative Site
Mesa, Arizona, 85210, United States
Novartis Investigative Site
Los Angeles, California, 90024, United States
Novartis Investigative Site
Oceanside, California, 92056, United States
Novartis Investigative Site
San Diego, California, 92103, United States
Novartis Investigative Site
San Diego, California, 92108, United States
Novartis Investigative Site
San Diego, California, 92123, United States
Novartis Investigative Site
Denver, Colorado, 80212, United States
Novartis Investigative Site
Daytona Beach, Florida, 32124, United States
Novartis Investigative Site
Fort Lauderdale, Florida, 33319, United States
Novartis Investigative Site
Miami, Florida, 33143, United States
Novartis Investigative Site
North Miami, Florida, 33161, United States
Novartis Investigative Site
North Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, 32806, United States
Novartis Investigative Site
Atlanta, Georgia, 30328, United States
Novartis Investigative Site
Smyrna, Georgia, 30080, United States
Novartis Investigative Site
Hoffman Estates, Illinois, 60169, United States
Novartis Investigative Site
Hoffman Estates, Illinois, 60194, United States
Novartis Investigative Site
Park Ridge, Illinois, 60068, United States
Novartis Investigative Site
Skokie, Illinois, 60076, United States
Novartis Investigative Site
Prairie Village, Kansas, 66206, United States
Novartis Investigative Site
Topeka, Kansas, 66606, United States
Novartis Investigative Site
Wichita, Kansas, 67207, United States
Novartis Investigative Site
Shreveport, Louisiana, 71103, United States
Novartis Investigative Site
Glen Burnie, Maryland, 21061, United States
Novartis Investigative Site
Las Vegas, Nevada, 89128, United States
Novartis Investigative Site
Kenilworth, New Jersey, 07033, United States
Novartis Investigative Site
Summit, New Jersey, 07901, United States
Novartis Investigative Site
Toms River, New Jersey, 08755, United States
Novartis Investigative Site
Brooklyn, New York, 11201, United States
Novartis Investigative Site
Cedarhurst, New York, 11516, United States
Novartis Investigative Site
Fresh Meadows, New York, 11366, United States
Novartis Investigative Site
New York, New York, 10021, United States
Novartis Investigative Site
New York, New York, 10023, United States
Novartis Investigative Site
Staten Island, New York, 10312, United States
Novartis Investigative Site
West Allis, New York, 53227, United States
Novartis Investigative Site
Raleigh, North Carolina, 27609, United States
Novartis Investigative Site
Cleveland, Ohio, 44122, United States
Novartis Investigative Site
Toledo, Ohio, 43623, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73103, United States
Novartis Investigative Site
Medford, Oregon, 97504, United States
Novartis Investigative Site
Portland, Oregon, 97210, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104, United States
Novartis Investigative Site
Memphis, Tennessee, 38119, United States
Novartis Investigative Site
Austin, Texas, 78756, United States
Novartis Investigative Site
Houston, Texas, 77008, United States
Novartis Investigative Site
Houston, Texas, 77090, United States
Novartis Investigative Site
Irving, Texas, 75062, United States
Novartis Investigative Site
Arlington, Virginia, 22201, United States
Novartis Investigative Site
Bellevue, Washington, 98004, United States
Novartis Investigative Site
Seattle, Washington, 98104, United States
Novartis Investigative Site
Milwaukee, Wisconsin, 53227, United States
Related Publications (1)
Stahl SM, Fava M, Trivedi MH, Caputo A, Shah A, Post A. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry. 2010 May;71(5):616-26. doi: 10.4088/JCP.09m05471blu. Epub 2010 Mar 23.
PMID: 20361916DERIVED
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