Status:
COMPLETED
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
Lead Sponsor:
Novartis
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-labe...
Eligibility Criteria
Inclusion
- Male and female adults, 18 through 70 years of age, inclusive
- Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
- A history of at least two previous episodes of Major Depression plus the current episode
- Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline
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
- Use of any psychoactive medication after the screening visit
- Patients who have been previously treated with agomelatine
- Female patients of childbearing potential who are not using effective contraception
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT00467402
Start Date
April 1 2007
Last Update
December 23 2020
Active Locations (78)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35226
2
Novartis Investigative Site
Peoria, Arizona, United States, 85381
3
Novartis Investigative Site
Tucson, Arizona, United States, 85724
4
Novartis Investigative Site
Beverly Hills, California, United States, 90210