Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.

Key facts

Study ID

NCT01110902

Run by

Novartis Pharmaceuticals

People needed

589

Starts

2010-05-01

Expected to finish

2011-06-01

Last updated by the study team

2020-12-24

Who can join

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

You may qualify if…

• Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
• Current episode ≥4 weeks.
• CGI-Severity score ≥4 at Screening and Baseline.

You may not qualify if…

• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
• Any other current Axis I disorder other than MDD 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.
• Prior exposure to agomelatine.
• Female patients of childbearing potential who are not using effective contraception.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Alabama at Birmingham, Department of Psychiatry — Birmingham, Alabama, United States
• ATP Clinical Research — Costa Mesa, California, United States
• Valley Clinical Research — El Centro, California, United States
• Collaborative Neuroscience Network — Garden Grove, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Affiliated Research Institute — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Viking Clinical Research — Temecula, California, United States
• ICSL Clinical Studies — Altamonte Springs, Florida, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Arocha Research Center — Coral Gables, Florida, United States
• Innova Clinical Trials — Miami, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
• Joliet Center for Clinical Research — Joliet, Illinois, United States
• CNS Clinical Trials — Park Ridge, Illinois, United States
• Deaconess Clinic — Evansville, Indiana, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Pharmasite Research — Pikesville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Clinical Trials — Brighton, Massachusetts, United States
• Mercy Health Research — St Louis, Missouri, United States
• Premier Psychiatry Group, LLC — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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