Agomelatine

Generic Name: Agomelatine

Brand Names: Valdoxan

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₇NO_₂

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: -

Clinical Trials

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

Phase 4

Recruiting

Conditions: Negative Symptoms in Schizophrenia
Schizophrenia

Interventions: Drug: Agomelatine

First Posted Date: 2022-12-12

Last Posted Date: 2022-12-12

Lead Sponsor: Shanghai Mental Health Center

Target Recruit Count: 220

Registration Number: NCT05646264

Locations: 🇨🇳
Shanghai Mental Health Center, Shanghai, China

Prophylactic Effects of Agomelatine for Poststroke Depression

Phase 4

Conditions: Acute Ischemic Stroke
Depression

Interventions: Drug: Placebo Tablets
Drug: Agomelatine

First Posted Date: 2022-06-21

Last Posted Date: 2022-07-27

Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Target Recruit Count: 420

Registration Number: NCT05426304

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

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebos
Drug: Agomelatine

First Posted Date: 2020-10-19

Last Posted Date: 2024-04-01

Lead Sponsor: Central South University

Target Recruit Count: 137

Registration Number: NCT04589143

Locations: 🇨🇳
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

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Other: electroconvulsive therapy
Drug: Placebo
Drug: agomelatine

First Posted Date: 2019-11-29

Last Posted Date: 2019-11-29

Lead Sponsor: Kaohsiung Kai-Suan Psychiatric Hospital

Target Recruit Count: 97

Registration Number: NCT04181567

Locations: 🇨🇳
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Phase 3

Withdrawn

Conditions: Depressive Disorder, Treatment-Resistant

Interventions: Drug: Esketamine 28 mg
Drug: Placebo
Drug: Esketamine 56 mg
Drug: Esketamine 84 mg
Drug: Escitalopram
Drug: Sertraline
Drug: Duloxetine
Drug: Mirtazapine
Drug: Agomelatine
Drug: Bupropion
Drug: Trazodone Prolonged Release

First Posted Date: 2019-02-25

Last Posted Date: 2019-11-26

Lead Sponsor: Janssen-Cilag International NV

Registration Number: NCT03852160

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3

Terminated

Conditions: Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders

Interventions: Drug: Phenobarbital
Drug: Phenytoin
Drug: Carbamazepine
Drug: Oxcarbazepine
Drug: Valproic Acid
Drug: Lamotrigine
Drug: Topiramate
Drug: Gabapentin
Drug: Levetiracetam
Drug: Pregabalin
Drug: Lacosamide
Drug: Clonazepam
Drug: Biperiden
Drug: Levomepromazine
Drug: Fluphenazine
Drug: Perphenazine
Drug: Perazine
Drug: Thioridazine
Drug: Haloperidol
Drug: Melperone
Drug: Pipamperone
Drug: Bromperidol
Drug: Benperidol
Drug: Sertindole
Drug: Ziprasidone
Drug: Flupentixol
Drug: Chlorprothixene
Drug: Zuclopenthixol
Drug: Fluspirilene
Drug: Pimozide
Drug: Clozapine
Drug: Olanzapine
Drug: Quetiapine
Drug: Sulpiride
Drug: Tiapride
Drug: Amisulpride
Drug: Prothipendyl
Drug: Risperidone
Drug: Aripiprazole
Drug: Paliperidone
Drug: Diazepam
Drug: Oxazepam
Drug: Lorazepam
Drug: Bromazepam
Drug: Clobazam
Drug: Alprazolam
Drug: Hydroxyzine
Drug: Buspirone
Drug: Chloral Hydrate
Drug: Flurazepam
Drug: Nitrazepam
Drug: Triazolam
Drug: Lormetazepam
Drug: Temazepam
Drug: Midazolam
Drug: Brotizolam
Drug: Zopiclone
Drug: Zolpidem
Drug: Zaleplon
Drug: Melatonin
Drug: Clomethiazole
Drug: Diphenhydramine
Drug: Promethazine
Drug: Imipramine
Drug: Clomipramine
Drug: Opipramol
Drug: Trimipramine
Drug: Amitriptyline
Drug: Nortriptyline
Drug: Doxepin
Drug: Maprotiline
Drug: Amitriptyline oxide
Drug: Fluoxetine
Drug: Citalopram
Drug: Paroxetine
Drug: Sertraline
Drug: Fluvoxamine
Drug: Escitalopram
Drug: Tranylcypromine
Drug: Moclobemide
Drug: Mianserin
Drug: Trazodone
Drug: Mirtazapine
Drug: Bupropion
Drug: Venlafaxine
Drug: Reboxetine
Drug: Duloxetine
Drug: Agomelatine
Drug: Pyritinol
Drug: Piracetam
Drug: Donepezil
Drug: Rivastigmine
Drug: Galantamine
Drug: Memantine
Drug: Nicergoline
Drug: Acamprosate
Drug: Lithium

First Posted Date: 2015-03-02

Last Posted Date: 2018-02-28

Lead Sponsor: Hannover Medical School

Target Recruit Count: 407

Registration Number: NCT02374567

Locations: 🇩🇪
Bezirkskrankenhaus Augsburg, Augsburg, Germany
🇩🇪
Krankenhaus Hedwigshöhe, Berlin, Germany
🇩🇪
Hannover Medical School, Hannover, Germany

and more 2 locations

Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder
Delusional Disorder

Interventions: Drug: agomelatine

First Posted Date: 2013-04-02

Last Posted Date: 2018-03-08

Lead Sponsor: Central Institute of Mental Health, Mannheim

Target Recruit Count: 27

Registration Number: NCT01822418

Locations: 🇩🇪
Central Institute of Mental Health, Mannheim, Baden-Württemberg, Germany

Agomelatine in Depressed Patients With Fibromyalgia

Completed

Conditions: Major Depression
Fibromyalgia

Interventions: Drug: agomelatine

First Posted Date: 2012-11-22

Last Posted Date: 2014-05-07

Lead Sponsor: Universidad de Granada

Target Recruit Count: 27

Registration Number: NCT01731899

Locations: 🇪🇸
Instituto de Neurociencias, Granada, Spain

A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Vortioxetine (Lu AA21004)
Drug: Agomelatine

First Posted Date: 2011-12-08

Last Posted Date: 2014-03-26

Lead Sponsor: H. Lundbeck A/S

Target Recruit Count: 495

Registration Number: NCT01488071

Cardiovascular Effects of Agomelatine and Escitalopram in Patients With Major Depressive Disorder (MDD)

Phase 4

Conditions: Major Depressive Disorder (MDD)

Interventions: Drug: Agomelatine
Drug: Escitalopram

First Posted Date: 2011-12-01

Last Posted Date: 2013-12-18

Lead Sponsor: Baker Heart and Diabetes Institute

Target Recruit Count: 40

Registration Number: NCT01483053

Locations: 🇦🇺
Monash Medical Centre - Monash Health, Clayton, Victoria, Australia
🇦🇺
Alfred and Baker Medical Unit - Alfred Hospital, Melbourne, Victoria, Australia
🇦🇺
Baker IDI Heart & Diabetes Institute, Melbourne, Victoria, Australia

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