Agomelatine

Generic Name
Agomelatine
Brand Names
Valdoxan
Drug Type
Small Molecule
Chemical Formula
C15H17NO2
CAS Number
138112-76-2
Unique Ingredient Identifier
137R1N49AD
Background

Agomelatine is structurally closely related to melatonin. Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. Agomelatine was developed in Europe by Servier Laboratories Ltd. and submitted to the European Medicines Agency (EMA) in 2005. The Committee for Medical...

Indication

Agomelatine is indicated to treat major depressive episodes in adults.

Associated Conditions
Major Depressive Episode
Associated Therapies
-

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-04-30
Last Posted Date
2020-12-23
Lead Sponsor
Novartis
Target Recruit Count
644
Registration Number
NCT00467402
Locations
🇺🇸

Novartis Investigative Site, West Allis, Wisconsin, United States

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)

First Posted Date
2007-04-20
Last Posted Date
2020-12-23
Lead Sponsor
Novartis
Target Recruit Count
501
Registration Number
NCT00463242
Locations
🇵🇷

Novartis Investigative Site, Hato Rey, Puerto Rico

The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder

Not Applicable
Withdrawn
Conditions
First Posted Date
2007-03-23
Last Posted Date
2008-01-08
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
24
Registration Number
NCT00451490
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

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

First Posted Date
2006-12-13
Last Posted Date
2020-12-23
Lead Sponsor
Novartis
Target Recruit Count
503
Registration Number
NCT00411242
Locations
🇺🇸

Novartis Investigative Site, Milwaukee, Wisconsin, United States

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

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-12-13
Last Posted Date
2020-12-23
Lead Sponsor
Novartis
Target Recruit Count
508
Registration Number
NCT00411099
Locations
🇵🇷

Novartis Investigative Site, Rio Piedras, Puerto Rico

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