MedPath

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 Products for Human Use (CHMP) recommended refusal of marketing authorization on 27 July 2006. The major concern was that efficacy had not been sufficiently shown. In 2006 Servier sold the rights to develop Agomelatine in the US to Novartis.

The development for the US market was discontinued in October 2011. It is currently sold in Australia under the Valdoxan trade name.

Indication

Agomelatine is indicated to treat major depressive episodes in adults.

Associated Conditions
Major Depressive Episode
Clinical Trials
Related News

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Phase 2
Recruiting
Conditions
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Interventions
Drug: Placebo
First Posted Date
2023-06-28
Last Posted Date
2024-07-08
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Target Recruit Count
200
Registration Number
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Site 119, Boise, Idaho, United States

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Site 344, Las Vegas, Nevada, United States

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A Study on the Efficacy of Agomelatine Combined With Antipsychotics to Treat Negative Symptoms in Schizophrenia

Phase 4
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First Posted Date
2022-12-12
Last Posted Date
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Prophylactic Effects of Agomelatine for Poststroke Depression

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A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine

Phase 4
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Interventions
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First Posted Date
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Last Posted Date
2024-04-01
Lead Sponsor
Central South University
Target Recruit Count
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Registration Number
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Locations
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Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University, Changsha, Hunan, China

Comparison of the Efficacy, Safety, and Relapse of ECT to ECT Plus Agomelatine for Depressed Patients

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Interventions
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2019-11-29
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Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan

the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease

Phase 4
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Melatonin Decreases Eye Pressure in Normotensive Patients

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First Posted Date
2017-06-20
Last Posted Date
2018-08-13
Lead Sponsor
Kahramanmaras Sutcu Imam University
Target Recruit Count
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Registration Number
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Krankenhaus Hedwigshöhe, Berlin, Germany

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Hannover Medical School, Hannover, Germany

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Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)

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First Posted Date
2013-04-02
Last Posted Date
2018-03-08
Lead Sponsor
Central Institute of Mental Health, Mannheim
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🇩🇪

Central Institute of Mental Health, Mannheim, Baden-Württemberg, Germany

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