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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00463242

Run by

Novartis

People needed

501

Starts

2007-03-01

Last updated by the study team

2020-12-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — National City, California, United States
• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — Pico Rivera, California, United States
• Novartis Investigative Site — Redlands, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Fort Myers, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Augusta, Georgia, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Joliet, Illinois, United States
• Novartis Investigative Site — Overland Park, Kansas, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Rockville, Maryland, United States
• Novartis Investigative Site — Fall River, Massachusetts, United States

Full record on ClinicalTrials.gov

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