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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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 a 52-week open-label phase.

Key facts

Study ID

NCT00411099

Run by

Novartis

People needed

508

Starts

2006-12-01

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…

• 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

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
• 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

Where it is running

• Novartis Investigative Site — Scottsdale, Arizona, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Cerritos, California, United States
• Novartis Investigative Site — El Centro, California, United States
• Novartis Investigative Site — Garden Grove, California, United States
• Novartis Investigative Site — Irvine, California, United States
• Novartis Investigative Site — Lafayette, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Temecula, California, United States
• Novartis Investigative Site — Cromwell, Connecticut, United States
• Novartis Investigative Site — Hamden, Connecticut, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Maitland, Florida, United States
• Novartis Investigative Site — Port Charlotte, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — Overland Park, Kansas, United States
• Novartis Investigative Site — Rockville, Maryland, United States
• Novartis Investigative Site — Salisbury, Maryland, United States
• Novartis Investigative Site — Pittsfield, Massachusetts, United States
• Novartis Investigative Site — Farmington Hills, Michigan, United States
• Novartis Investigative Site — Rochester Hills, Michigan, United States
• Novartis Investigative Site — City of Saint Peters, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.