A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg
1 other identifier
interventional
501
2 countries
47
Brief Summary
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.
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
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedDecember 23, 2020
May 1, 2012
1.3 years
April 19, 2007
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
8 weeks
Secondary Outcomes (4)
To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX).
8 weeks
Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8.
8 weeks
Proportion of patients with MDD who achieve remission,
8 weeks
Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).
8 weeks
Study Arms (3)
Agomelatine
EXPERIMENTALDosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.
2
ACTIVE COMPARATOR3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female adults, 18 through 70 years of age, inclusive
- Diagnosis of Major Depressive Disorder according to DSM-IV criteria
- HAM-D17 total score \> or = 22 at Screening and Baseline
You may not qualify if:
- History of non-response to paroxetine
- Patients who have been previously treated with agomelatine
- 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
- Use of any psychoactive medication after the screening visit
- Female patients of childbearing potential who are not using effective contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (47)
Novartis Investigative Site
Phoenix, Arizona, 85016, United States
Novartis Investigative Site
National City, California, 91950, United States
Novartis Investigative Site
Orange, California, 92868, United States
Novartis Investigative Site
Pasadena, California, 91105, United States
Novartis Investigative Site
Pico Rivera, California, 90660, United States
Novartis Investigative Site
Redlands, California, 92374, United States
Novartis Investigative Site
San Diego, California, 92120, United States
Novartis Investigative Site
San Diego, California, 92126, United States
Novartis Investigative Site
Torrance, California, 90502, United States
Novartis Investigative Site
Colorado Springs, Colorado, 80909, United States
Novartis Investigative Site
Boca Raton, Florida, 33431, United States
Novartis Investigative Site
Fort Myers, Florida, 33912, United States
Novartis Investigative Site
Jacksonville, Florida, 32216, United States
Novartis Investigative Site
Jacksonville, Florida, 32256, United States
Novartis Investigative Site
Miami, Florida, 33143, United States
Novartis Investigative Site
Orlando, Florida, 32806, United States
Novartis Investigative Site
Winter Park, Florida, 32789, United States
Novartis Investigative Site
Augusta, Georgia, 30912, United States
Novartis Investigative Site
Honolulu, Hawaii, 96813, United States
Novartis Investigative Site
Joliet, Illinois, 60435, United States
Novartis Investigative Site
Overland Park, Kansas, 66212, United States
Novartis Investigative Site
Baltimore, Maryland, 21205, United States
Novartis Investigative Site
Baltimore, Maryland, 21208, United States
Novartis Investigative Site
Rockville, Maryland, 20852, United States
Novartis Investigative Site
Fall River, Massachusetts, 02721, United States
Novartis Investigative Site
Okemos, Michigan, 48864, United States
Novartis Investigative Site
Saint Charles, Missouri, 63301, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Lincoln, Nebraska, 68510, United States
Novartis Investigative Site
Willingboro, New Jersey, 08046, United States
Novartis Investigative Site
New York, New York, 10024, United States
Novartis Investigative Site
Charlotte, North Carolina, 28211, United States
Novartis Investigative Site
Durham, North Carolina, 27710, United States
Novartis Investigative Site
Canton, Ohio, 44718, United States
Novartis Investigative Site
Corvallis, Oregon, 97330, United States
Novartis Investigative Site
Erie, Pennsylvania, 16506, United States
Novartis Investigative Site
Media, Pennsylvania, 19063, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104, United States
Novartis Investigative Site
Austin, Texas, 78756, United States
Novartis Investigative Site
Dallas, Texas, 75230, United States
Novartis Investigative Site
Friendswood, Texas, 77546, United States
Novartis Investigative Site
Houston, Texas, 77008, United States
Novartis Investigative Site
Herndon, Virginia, 20170, United States
Novartis Investigative Site
Richmond, Virginia, 23230, United States
Novartis Investigative Site
Bellevue, Washington, 98004, United States
Novartis Investigative Site
Waukesha, Wisconsin, 53188, United States
Novartis Investigative Site
Hato Rey, 00918, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 19, 2007
First Posted
April 20, 2007
Study Start
March 1, 2007
Primary Completion
June 1, 2008
Last Updated
December 23, 2020
Record last verified: 2012-05