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

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

NCT01110889

Run by

Novartis Pharmaceuticals

People needed

582

Starts

2010-05-01

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…

• 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

• Birmingham Psychiatry — Birmingham, Alabama, United States
• Southwestern Research Institute — Beverly Hills, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Mood & Anxiety Research — Fresno, California, United States
• Excell Research, Inc — Oceanside, California, United States
• Cnri-La, Llc — Pico Rivera, California, United States
• CNRI San Diego — San Diego, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Western Affiliated Research Institute — Denver, Colorado, United States
• Clinical Research Institute of South Florida — Hialeah, Florida, United States
• Florida Clinical Research Center LLC — Maitland, Florida, United States
• CNS Healthcare — Orlando, Florida, United States
• Broward Research Group — Pembroke Pines, Florida, United States
• Quantum Lab. N. Broward Memory Disorder Center — Pompano Beach, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Northwest Behavioral Research Center — Marietta, Georgia, United States
• Hawaii Clinical Research Center — Honolulu, Hawaii, United States
• Mountain West Clinical Trials — Eagle, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• CTT Clinical Trials Technology — Prairie Village, Kansas, United States
• Clinical Trials Management — Metairie, Louisiana, United States
• Mount Auburn Medical Associates — Watertown, Massachusetts, United States
• Coastal Research Associates — Weymouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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