Status:
COMPLETED
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Lead Sponsor:
Novartis
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT00411099
Start Date
December 1 2006
Last Update
December 23 2020
Active Locations (44)
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1
Novartis Investigative Site
Scottsdale, Arizona, United States, 85251
2
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
3
Novartis Investigative Site
Cerritos, California, United States, 90703
4
Novartis Investigative Site
El Centro, California, United States, 92243