Status:
COMPLETED
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)
Lead Sponsor:
Novartis
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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-bli...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00463242
Start Date
March 1 2007
Last Update
December 23 2020
Active Locations (47)
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1
Novartis Investigative Site
Phoenix, Arizona, United States, 85016
2
Novartis Investigative Site
National City, California, United States, 91950
3
Novartis Investigative Site
Orange, California, United States, 92868
4
Novartis Investigative Site
Pasadena, California, United States, 91105