Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.

Key facts

Study ID

NCT00467402

Run by

Novartis

People needed

644

Starts

2007-04-01

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, 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Peoria, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Costa Mesa, California, United States
• Novartis Investigative Site — Encino, California, United States
• Novartis Investigative Site — Glendale, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Newport Beach, California, United States
• Novartis Investigative Site — Oceanside, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Sherman Oaks, California, United States
• Novartis Investigative Site — Temecula, California, United States
• Novartis Investigative Site — Wheat Ridge, Colorado, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Coral Springs, Florida, United States
• Novartis Investigative Site — Fort Myers, Florida, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Venice, Florida, United States
• Novartis Investigative Site — West Palm Beach, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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