agomelatine / Generic mfg. 
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42 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
agomelatine / Generic mfg.
2009-010642-57: “Efficacy and safety of ValdoxanR given orally once a day for 24 weeks in patients with Major Depressive Disorder.” Open, national, multicentric clinical trial for the evaluation of the antidepressant efficacy and tolerability of ValdoxanR and its additional clinical benefits for depressed patients.

Ongoing
4
160
Europe
S20098, S20098, Film-coated tablet, VALDOXAN
Servier Slovensko, spol. s.r.o.
Major Depressive Disorder
 
 
2009-016953-16: Depressions-Spektrums-Störung und differenzielle Effekte neuerer Antidepressiva auf die Verkehrssicherheit

Ongoing
4
120
Europe
Cipralex, Solvex, Remergil, Elontril, Valdoxan, Tablet, Cipralex, Solvex, Remergil, Elontril, Valdoxan
Inn-Salzach-Klinikum gGmbH
Spectrum of depressive diseases, ICD-10: F32.x, F33.x
 
 
2013-003370-27: Functional changes in the brain after application of antidepressants and their clinical impact, their relation to the stress hormone system and to the enterobacteria Bildgebung des Kopfes nach Behandlung mit Antidepressiva sowie der Zusammenhang zum klinischen Verlauf, zum Stresshormonsystem und zu den Darmbakterien

Ongoing
4
80
Europe
Coated tablet, Mirtazapin-CT, Cipralex, Valdoxan
Rainer Rupprecht, Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum, Universität(sklinikum) Regensburg, Bundesministerium für Bildung und Forschung
Major Depressive Disorder is a chronic stress related disorder characterized by depressed mood and by vegetative and cognitive symptoms. Moreover, genetic, neuroendocrine and neurochemical biomarkers may predict impaired processing and regulation of emotions related to major depression as well as antidepressant treatment response in general. There is evidence, that the gut microbiome may influence stress, anxiety and depression-related behavior via effects on the host´s neuroendocrine system. Depression ist eine stressassoziierte Störung, charakterisiert durch gedrückte Stimmung, vegetative und kognitive Symptome. Außerdem könnten genetische, neuroendokrine, -chemische Biomarker Vorhersagen treffen über gestörte Verarbeitung/Regulation von Emotionen in Zusammenhang mit Depression sowie über das Ansprechen auf antidepressive Therapie. Es gibt Anhaltspunkte, dass das Dickdarm-Mikrobiom womöglich Einfluss hat auf Stress und Angst durch Effekte auf das neuroendokrine System des Wirtes., Disease characterized by depressed mood and by vegetative Symptoms (e.g. sleep disturbance, dimished appetite) and cognitive symptoms (e.g. reduced attention) Krankheitsbild charakterisiert durch gedrückte Stimmung, vegetative (z.B. Schlafstörungen, Appetitlosigkeit) und kognitive Symptome (z.B. Aufmerksamkeitsstörungen)., Diseases [C] - Nervous System Diseases [C10]
 
 
2008-008220-32: Efficacité clinique de VALDOXAN dans les conditions de pratique quotidienne (efficience) chez des patients déprimés, en switch ou naïfs de traitement Etude clinique interventionelle de phase IV, multicentrique, ouverte. Etude VALDOXAN D-CHANGE.

Ongoing
4
4000
Europe
S20098, S20098, VALDOXAN, VALDOXAN
EUTHERAPIE pour le compte du promoteur Les Laboratoires Servier
Episode depressif majeur
 
 
2009-010112-15: Effets cliniques de VALDOXAN® (25 ou 50mg) à long terme chez des patients déprimés - Etude clinique, nationale, interventionnelle de phase IV, multicentrique, réalisée en ouvert.Etude Valdoxan D - EXTENSION

Ongoing
4
3200
Europe
S20098, S20098, VALDOXAN, VALDOXAN
EUTHERAPIE pour le compte du promoteur Les Laboratoires Servier
Episode depressif majeur
 
 
2009-012560-14: Réponse au VALDOXAN® et restauration des rythmes de vie dans la dépression unipolaire : Etude VALDOXAN® D-Rhythm.Etude clinique interventionnelle de phase IV, multicentrique

Ongoing
4
1600
Europe
S20098, S20098, VALDOXAN, VALDOXAN
EUTHERAPIE / Les Laboratoires Servier
Episode depressif majeur
 
 
2010-021044-17: The effect of agomelatine on CLOCK gene expression in patients with major depressive disorder and healthy controls: an exploratory study.

Ongoing
4
60
Europe
agomelatin, Valdoxan, Valdoxan
Medizinische Universität Wien
Major depressive disorder (MDD), Seasonal affective disorder (subtype of MDD)
 
 
2010-019423-61: GENRAS(GENetics of Response to Agomelatine vs. EScitalopram)

Ongoing
4
400
Europe
CIPRALEX - Filmtabletten 10 mg, VALDOXAN 25 mg - Filmtabletten, CIPRALEX - Filmtabletten 10 mg, VALDOXAN 25 mg - Filmtabletten, CIPRALEX - Filmtabletten 10 mg, VALDOXAN 25 mg - Filmtabletten
Medizinische Universität Wien,Univ.Klinik f.Psychiatrie und Psychotherapie
depressive disorder
 
 
2010-023473-18: Verkehrssicherheit unter Agomelatin

Ongoing
4
40
Europe
Valdoxan, Trevilor retard, Valdoxan, Trevilor retard, Valdoxan, Trevilor retard
Inn-Salzach-Klinikum gGmbH
Diagnosis of depression; ICD-10: F32.x, F33.x
 
 
2017-000990-35: Effects of the antidepressive therapy with Agomelatin and Escitalopram in people with depression and epilepsy Effetti della terapia antidepressiva utilizzando Agomelatina ed Escitalopram in persone con depressione ed epilessia

Ongoing
4
208
Europe
Agomelatina, Escitalopram, n.a., Film-coated tablet, VALDOXAN - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/PVC) 7 COMPRESSE, ESCITALOPRAM ACCORD - " 10 MG COMPRESSE RIVESTITE CON FILM " 98 COMPRESSE IN BLISTER AL/AL
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
Depression in patients affected by epilepsy Depressione in pazienti affetti da epilessia, Depression in person with epilepsy Depressione in persone con epilessia, Diseases [C] - Nervous System Diseases [C10]
 
 
ChiCTR2200066866: Efficacy and safety of Agomelatine monotherapy in the treatment of depression: a multicenter, open-ended study

Completed
4
93
 
Agomelatine monotherapy
Beijing Anding Hospital Affiliated to Capital Medical University; Beijing Anding Hospital Affiliated to Capital Medical University, Jiangsu Hausen Pharmaceutical Co., LTD
Major depressive disorder
 
 
ChiCTR1800020182: A control study for sertraline and agomelatine on insomnia symptoms in patients with depression

Recruiting
4
80
 
agomelatine 25-75mg per day before sleep ;sertraline 50-200mg per day before sleep
Kangci Hospital of Jiaxing; Level of the institution：, Subject funds of Tongxiang
Dpression
 
 
ChiCTR2100045530: A preliminary study on the efficacy and safety of proton pump inhibitors combined with agomelatine in the treatment of gastroesophageal reflux disease

Recruiting
4
80
 
On the basis of proton pump inhibitor (rabeprazole 20mg, orally, 1 day), agomelatine 25mg/d was added, orally before bedtime ;On the basis of proton pump inhibitor (rabeprazole 20mg, orally, 1/ day) treatment, soothing agents were added, orally before bedtime
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Jiangsu Hansoh Pharmaceutical Group Co. Ltd
Gastroesophageal reflux disease (GERD)
 
 
NCT04589143: A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine

Completed
4
137
RoW
Agomelatine, Placebos
Central South University
Major Depressive Disorder
12/22
01/23
ChiCTR1800018822: A randomized, double-blind, controlled trial for investigation of the improvement of agomelatine combined cognitive behavioral therapy in patients with chronic insomnia with mild depression

Recruiting
4
300
 
placebo pill ;Agomelatine pill ;Zolpidem Tartrate pill
Changzheng Hospital of Second Miliatary Medical University; Changzheng Hospital of Second Miliatary Medical University, research projects
chronic insomnia and depression
 
 
ACTRN12621000601831: Agomelatine in Depression: An Open-Label Study of Agomelatine in Adults with Major Depressive Disorder

Completed
4
30
 
Alto Neuroscience (Australia) Pty Ltd, Alto Neuroscience (Australia) Pty Ltd
Major Depressive Disorder
 
 
ChiCTR2100048875: A multicenter, randomized, double-blind, placebo-controlled trial of the efficacy and safety of agomelatine in patients with rapid eye movement (REM) sleep behavior disorder (RBD)

Not yet recruiting
4
50
 
Agomelatine 25mg/d, oral treatment before sleep, the dose was increased to 50mg/d after 2 weeks of treatment if no liver impairment occurs ;Placebo, oral treatment before sleep
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Jiangsu Hansoh Pharmaceutical Group Co., Ltd
Rapid eye movement (REM) sleep behavior disorder (RBD)
 
 
ChiCTR2000032518: Efficacy and safety of agomelatine combined with SSRIs in depressive disorder: a randomized controlled trial

Recruiting
4
120
 
Treat with the combination of SSRIs (sertraline or escitalopram) in the first 6 weeks.Those whose efficacy is well in the first stage of treatment will continue to receive the original drug and the same dose.Others who did not respond to the treatment will be given a combination of sertraline or esc ;Treat with Agomelatine in the first 6 weeks.Those whose efficacy is well in the first stage of treatment will continue to receive the original drug and the same dose.Others who did not respond to the treatment will be given a combination of sertraline or escitalopram with agomelatine.
Shandong Mental Health Center; Shandong Mental Health Center, Teachers' Scientific Research Support Fund of Jining Medical College
Major Depressive Disorder
 
 
ChiCTR2200061464: The use of real-world evidence for evaluating the efficacy and side effects of agomelatine in the treatment of major depressive disorder

Not yet recruiting
4
1380
 
None
Zhongda Hospital, School of Medicine, Southeast University; Zhongda Hospital, School of Medicine, Southeast University, self-raised
major depressive disorder (MDD)
 
 
NCT05646264: A Study on the Efficacy of Agomelatine Combined With Antipsychotics to Treat Negative Symptoms in Schizophrenia

Recruiting
4
220
RoW
Agomelatine
Shanghai Mental Health Center, Tianjin Anding Hospital
Schizophrenia, Negative Symptoms in Schizophrenia
08/23
08/23
PRAISED, NCT05426304: Prophylactic Effects of Agomelatine for Poststroke Depression

Not yet recruiting
4
420
NA
Agomelatine, Agomelatine Tablets, Placebo Tablets, Placebo Placebo
First Affiliated Hospital, Sun Yat-Sen University
Depression, Acute Ischemic Stroke
05/24
05/24
ChiCTR-TRC-11001668: Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder.

Completed
3
628
 
Oral Valdoxan, Agomelatine, 25 or 50mg, tablets ;Oral Prozac, Fluoxetine, 20 or 40mg capsules
Institut de Recherche Internationales Servier; Level of the institution：, Institut de Recherche Internationales Servier
Major Depressive Disorder
 
 
2011-005320-17: Effects of agomelatine on emotional experiences in depressed adults patients as compared to escitalopram

Ongoing
3
500
Europe
S20098, S20098, Capsule, VALDOXAN, SEROPLEX, CIPRALEX
Institut de Recherches Internationales Servier, SRDL, Servier Research and Develpment
Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2006-006540-54: Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day).Twelve-week treatment plus double-blind extension for 12 weeks.

Ongoing
3
100
Europe
S20098, S20098, CIPRALEX, CIPRALEX
Institut de Recherches Internationales Servier, Servier Research and Development Limited
Major Depressive Disorder
 
 
2008-003421-17: Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment at 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder.A 12-week randomised, double-blind, placebo-controlled, with paroxetine (20 mg/day with potential progressive blinded adjustment to 40 mg/day) as validator, 3-arm parallel groups, international multicenter study.

Ongoing
3
40
Europe
S20098, S20098, SEROXAT, SEROXAT
Institut de Recherches Internationales Servier
Generalized Anxiety Disorder
 
 
2015-002181-23: Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with moderate to severe Major Depressive Disorder.

Ongoing
3
484
Europe, RoW
Agomelatine, Fluoxetine, S20098, Film-coated tablet, Oral solution, Valdoxan, Fluoxetine
Institut de Recherche International Servier, ADIR
Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2011-003313-42: Agomelatine efficacy of the drug to improve sleep problems in autistic people Eficacia del fármaco agomelatina para mejorar los problemas del sueño en personas autistas

Ongoing
2
40
Europe
Agomelatine, Tablet, Valdoxan 25mg
Hospital General Universitario de Alicante, Hospital General Universitario de Alicante
The treatment of sleep disorders in patients with autism spectrum disorders (ASD) El tratamiento de los trastornos del sueño en los pacientes con trastornos del espectro autista (TEA), The treatment of sleep problems in autistic patients El tratamiento de los problemas del sueño en los pacientes autistas, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2004-002577-23: Efficacy and safety of Agomelatine (25 mg with potential adjustment at 50 mg) given orally once a day for 12 weeks in out-patients with Generalised Anxiety Disorder. A randomised flexible dose double-blind, placebo-controlled, parallel groups, international study.

Ongoing
2
80
Europe
S20098-F55,
Institut de Recherches Internationales Servier
Generalised Anxiety Disorder
 
 
2007-005564-27: Effect of agomelatine (25 mg) given orally once a day for 7 days on cerebral activity measured by functional MRI during processing of emotional stimuli in patients with Major Depressive Disorder. A randomised, double-blind, placebo-controlled study with an open extension period of 6 months with agomelatine (25 mg).Comparison to functional MRI profiles of healthy volunteers.

Ongoing
2
60
Europe
S20098, S20098,
Institut de Recherches Internationales Servier
Major Depressive Disorder
 
 
ChiCTR-TTRCC-13003835: Stuy on the Variability of Agomelatine

Completed
1
16
 
a single oral dose of 25mg agomelatine
the Third Xiangya Hospital of Central South University; the Third Xiangya Hospital of Central South University, This work was supported by the National Scientific Foundation of China (No. 81373476, 81302851, 81301924)
depression
 
 
ChiCTR-TRC-13003179: The different effects of agomelatine and escitalopram on the circadian rhythmic system in the first episode depressive patients

Completed
1
90
 
agomelatine 25-50mg per day before sleep ;escitalopram 10-20mg per day after breakfast ;No intervention
National Institute on Drug Dependence, Peking University; Level of the institution：, Natural Science Foundation of China
Depression
 
 
ChiCTR-IOR-17013734: The control study of mirtazapine and agomelatine on insomnia symptoms in patients with major depressive disorder

Completed
N/A
30
 
mirtazapine versus agomelatine
Peking University Sixth Hospital; Peking University Sixth Hospital, self fund project
major depressive disorder
 
 
ChiCTR2000031387: A retrospective study for the liver safety of agomelatine in the treatment of depression in the real world was analyzed based on the big data model algorithm

Not yet recruiting
N/A
50000
 
N/A ;N/A
Peking University Sixth Hospital; Peking University Sixth Hospital, Horizontal topic
Depressive disorder
 
 
ChiCTR2000037370: A randomized controlled clinical study on the improvement of cognitive impairment in patients with schizophrenia by replacing BDZ with agomelatin

Recruiting
N/A
100
 
Agomelatine ;No intervention
Shanghai Mental Health Center; Shanghai Mental Health Center, Shanghai Shenkang Hospital Development Center
Schizophrenia
 
 
ChiCTR2100046289: Efficacy and safety of agomelatine in patients epilepsy coexisting with depression on mood and cognitive function

Recruiting
N/A
50
 
placebo pill ;agomelatine 25mg ;agomelatine 50mg
Xuanwu Hospital Capital Medical University; Xuanwu Hospital Capital Medical University, research projects
Epilepsy with depression
 
 
NCT05952713: Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder

Completed
N/A
73336
Europe
Antidepressant, sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
Mental Health Services in the Capital Region, Denmark, University of Copenhagen
Major Depressive Disorder
07/23
07/23
ChiCTR2000034739: Study on the optimization of treatment scheme for patients with chronic insomnia

Not yet recruiting
N/A
180
 
trazodone ;Mirtazapine ;Fluvoxamine ;CBTI combined with hypnotic therapy ;Agomelatine ;nothing
The Second Affiliated Hospital of Xinxiang Medical University; The Second Affiliated Hospital of Xinxiang Medical University, Not available
Non-organic insomnia
 
 
ChiCTR2400090044: A real-world study of the efficacy and safety of agomelatine in combination with second-generation antipsychotics for the treatment of negative symptoms in patients with schizophrenia

Completed
N/A
80
 
Agomelatine in combination with second-generation antipsychotics; Second-generation antipsychotics alone
Jingzhou Mental Health Center; Jingzhou Mental Health Center, Joint Fund projects
schizofrenia
 
 
ChiCTR2100043512: Effect of agomelatine on cognitive dysfunction in schizophrenia

Recruiting
N/A
120
 
Agomelatine ;none
The Second Affiliated Hospital of Xinxiang Medical College; The Second Affiliated Hospital of Xinxiang Medical University, The Second Affiliated Hospital of Xinxiang Medical University
Schizophrenia
 
 
ChiCTR2200065883: Effects of agomelatine on occurrence of sleep bruxism: preliminary findings

Not yet recruiting
N/A
34
 
Placebo intervention + Agomelatine intervention at least 24 hours after placebo intervention ;Agomelatine intervention + Placebo intervention at least 24 hours after agomelatine intervention
Jiangxi Provincial People's Hospital; Jiangxi Provincial People's Hospital, Jiangxi Provincial People's Hospital Grant 2019-009
Sleep bruxism
 
 
NCT06120543: CYP1A2, ABCB1, CYP2C9 and Plasma Concentration of Agomelatine in Adult Patients With Depression

Not yet recruiting
N/A
50
NA
Affiliated Hospital of Nantong University
Polymorphism, Genetic, Depression, CYP1A2 Polymorphism, CYP2C9 Polymorphism, Polymerase Chain Reaction, Plasma Concentration
12/24
03/25
ChiCTR2300075165: Efficacy and Safety of Agomelatine in Epilepsy Patients With Inpaired Sleep and Mood Disorders: an Observational,Open,and Retrospective study

Recruiting
N/A
280
 
None; None
Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University; Shandong Provincial Hospital, None
Epilepsy Patients With Inpaired Sleep and Mood Disorders
 
 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
agomelatine / Generic mfg.
2009-010642-57: “Efficacy and safety of ValdoxanR given orally once a day for 24 weeks in patients with Major Depressive Disorder.” Open, national, multicentric clinical trial for the evaluation of the antidepressant efficacy and tolerability of ValdoxanR and its additional clinical benefits for depressed patients.

Ongoing
4
160
Europe
S20098, S20098, Film-coated tablet, VALDOXAN
Servier Slovensko, spol. s.r.o.
Major Depressive Disorder
 
 
2009-016953-16: Depressions-Spektrums-Störung und differenzielle Effekte neuerer Antidepressiva auf die Verkehrssicherheit

Ongoing
4
120
Europe
Cipralex, Solvex, Remergil, Elontril, Valdoxan, Tablet, Cipralex, Solvex, Remergil, Elontril, Valdoxan
Inn-Salzach-Klinikum gGmbH
Spectrum of depressive diseases, ICD-10: F32.x, F33.x
 
 
2013-003370-27: Functional changes in the brain after application of antidepressants and their clinical impact, their relation to the stress hormone system and to the enterobacteria Bildgebung des Kopfes nach Behandlung mit Antidepressiva sowie der Zusammenhang zum klinischen Verlauf, zum Stresshormonsystem und zu den Darmbakterien

Ongoing
4
80
Europe
Coated tablet, Mirtazapin-CT, Cipralex, Valdoxan
Rainer Rupprecht, Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg am Bezirksklinikum, Universität(sklinikum) Regensburg, Bundesministerium für Bildung und Forschung
Major Depressive Disorder is a chronic stress related disorder characterized by depressed mood and by vegetative and cognitive symptoms. Moreover, genetic, neuroendocrine and neurochemical biomarkers may predict impaired processing and regulation of emotions related to major depression as well as antidepressant treatment response in general. There is evidence, that the gut microbiome may influence stress, anxiety and depression-related behavior via effects on the host´s neuroendocrine system. Depression ist eine stressassoziierte Störung, charakterisiert durch gedrückte Stimmung, vegetative und kognitive Symptome. Außerdem könnten genetische, neuroendokrine, -chemische Biomarker Vorhersagen treffen über gestörte Verarbeitung/Regulation von Emotionen in Zusammenhang mit Depression sowie über das Ansprechen auf antidepressive Therapie. Es gibt Anhaltspunkte, dass das Dickdarm-Mikrobiom womöglich Einfluss hat auf Stress und Angst durch Effekte auf das neuroendokrine System des Wirtes., Disease characterized by depressed mood and by vegetative Symptoms (e.g. sleep disturbance, dimished appetite) and cognitive symptoms (e.g. reduced attention) Krankheitsbild charakterisiert durch gedrückte Stimmung, vegetative (z.B. Schlafstörungen, Appetitlosigkeit) und kognitive Symptome (z.B. Aufmerksamkeitsstörungen)., Diseases [C] - Nervous System Diseases [C10]
 
 
2008-008220-32: Efficacité clinique de VALDOXAN dans les conditions de pratique quotidienne (efficience) chez des patients déprimés, en switch ou naïfs de traitement Etude clinique interventionelle de phase IV, multicentrique, ouverte. Etude VALDOXAN D-CHANGE.

Ongoing
4
4000
Europe
S20098, S20098, VALDOXAN, VALDOXAN
EUTHERAPIE pour le compte du promoteur Les Laboratoires Servier
Episode depressif majeur
 
 
2009-010112-15: Effets cliniques de VALDOXAN® (25 ou 50mg) à long terme chez des patients déprimés - Etude clinique, nationale, interventionnelle de phase IV, multicentrique, réalisée en ouvert.Etude Valdoxan D - EXTENSION

Ongoing
4
3200
Europe
S20098, S20098, VALDOXAN, VALDOXAN
EUTHERAPIE pour le compte du promoteur Les Laboratoires Servier
Episode depressif majeur
 
 
2009-012560-14: Réponse au VALDOXAN® et restauration des rythmes de vie dans la dépression unipolaire : Etude VALDOXAN® D-Rhythm.Etude clinique interventionnelle de phase IV, multicentrique

Ongoing
4
1600
Europe
S20098, S20098, VALDOXAN, VALDOXAN
EUTHERAPIE / Les Laboratoires Servier
Episode depressif majeur
 
 
2010-021044-17: The effect of agomelatine on CLOCK gene expression in patients with major depressive disorder and healthy controls: an exploratory study.

Ongoing
4
60
Europe
agomelatin, Valdoxan, Valdoxan
Medizinische Universität Wien
Major depressive disorder (MDD), Seasonal affective disorder (subtype of MDD)
 
 
2010-019423-61: GENRAS(GENetics of Response to Agomelatine vs. EScitalopram)

Ongoing
4
400
Europe
CIPRALEX - Filmtabletten 10 mg, VALDOXAN 25 mg - Filmtabletten, CIPRALEX - Filmtabletten 10 mg, VALDOXAN 25 mg - Filmtabletten, CIPRALEX - Filmtabletten 10 mg, VALDOXAN 25 mg - Filmtabletten
Medizinische Universität Wien,Univ.Klinik f.Psychiatrie und Psychotherapie
depressive disorder
 
 
2010-023473-18: Verkehrssicherheit unter Agomelatin

Ongoing
4
40
Europe
Valdoxan, Trevilor retard, Valdoxan, Trevilor retard, Valdoxan, Trevilor retard
Inn-Salzach-Klinikum gGmbH
Diagnosis of depression; ICD-10: F32.x, F33.x
 
 
2017-000990-35: Effects of the antidepressive therapy with Agomelatin and Escitalopram in people with depression and epilepsy Effetti della terapia antidepressiva utilizzando Agomelatina ed Escitalopram in persone con depressione ed epilessia

Ongoing
4
208
Europe
Agomelatina, Escitalopram, n.a., Film-coated tablet, VALDOXAN - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/PVC) 7 COMPRESSE, ESCITALOPRAM ACCORD - " 10 MG COMPRESSE RIVESTITE CON FILM " 98 COMPRESSE IN BLISTER AL/AL
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
Depression in patients affected by epilepsy Depressione in pazienti affetti da epilessia, Depression in person with epilepsy Depressione in persone con epilessia, Diseases [C] - Nervous System Diseases [C10]
 
 
ChiCTR2200066866: Efficacy and safety of Agomelatine monotherapy in the treatment of depression: a multicenter, open-ended study

Completed
4
93
 
Agomelatine monotherapy
Beijing Anding Hospital Affiliated to Capital Medical University; Beijing Anding Hospital Affiliated to Capital Medical University, Jiangsu Hausen Pharmaceutical Co., LTD
Major depressive disorder
 
 
ChiCTR1800020182: A control study for sertraline and agomelatine on insomnia symptoms in patients with depression

Recruiting
4
80
 
agomelatine 25-75mg per day before sleep ;sertraline 50-200mg per day before sleep
Kangci Hospital of Jiaxing; Level of the institution：, Subject funds of Tongxiang
Dpression
 
 
ChiCTR2100045530: A preliminary study on the efficacy and safety of proton pump inhibitors combined with agomelatine in the treatment of gastroesophageal reflux disease

Recruiting
4
80
 
On the basis of proton pump inhibitor (rabeprazole 20mg, orally, 1 day), agomelatine 25mg/d was added, orally before bedtime ;On the basis of proton pump inhibitor (rabeprazole 20mg, orally, 1/ day) treatment, soothing agents were added, orally before bedtime
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Jiangsu Hansoh Pharmaceutical Group Co. Ltd
Gastroesophageal reflux disease (GERD)
 
 
NCT04589143: A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine

Completed
4
137
RoW
Agomelatine, Placebos
Central South University
Major Depressive Disorder
12/22
01/23
ChiCTR1800018822: A randomized, double-blind, controlled trial for investigation of the improvement of agomelatine combined cognitive behavioral therapy in patients with chronic insomnia with mild depression

Recruiting
4
300
 
placebo pill ;Agomelatine pill ;Zolpidem Tartrate pill
Changzheng Hospital of Second Miliatary Medical University; Changzheng Hospital of Second Miliatary Medical University, research projects
chronic insomnia and depression
 
 
ACTRN12621000601831: Agomelatine in Depression: An Open-Label Study of Agomelatine in Adults with Major Depressive Disorder

Completed
4
30
 
Alto Neuroscience (Australia) Pty Ltd, Alto Neuroscience (Australia) Pty Ltd
Major Depressive Disorder
 
 
ChiCTR2100048875: A multicenter, randomized, double-blind, placebo-controlled trial of the efficacy and safety of agomelatine in patients with rapid eye movement (REM) sleep behavior disorder (RBD)

Not yet recruiting
4
50
 
Agomelatine 25mg/d, oral treatment before sleep, the dose was increased to 50mg/d after 2 weeks of treatment if no liver impairment occurs ;Placebo, oral treatment before sleep
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Jiangsu Hansoh Pharmaceutical Group Co., Ltd
Rapid eye movement (REM) sleep behavior disorder (RBD)
 
 
ChiCTR2000032518: Efficacy and safety of agomelatine combined with SSRIs in depressive disorder: a randomized controlled trial

Recruiting
4
120
 
Treat with the combination of SSRIs (sertraline or escitalopram) in the first 6 weeks.Those whose efficacy is well in the first stage of treatment will continue to receive the original drug and the same dose.Others who did not respond to the treatment will be given a combination of sertraline or esc ;Treat with Agomelatine in the first 6 weeks.Those whose efficacy is well in the first stage of treatment will continue to receive the original drug and the same dose.Others who did not respond to the treatment will be given a combination of sertraline or escitalopram with agomelatine.
Shandong Mental Health Center; Shandong Mental Health Center, Teachers' Scientific Research Support Fund of Jining Medical College
Major Depressive Disorder
 
 
ChiCTR2200061464: The use of real-world evidence for evaluating the efficacy and side effects of agomelatine in the treatment of major depressive disorder

Not yet recruiting
4
1380
 
None
Zhongda Hospital, School of Medicine, Southeast University; Zhongda Hospital, School of Medicine, Southeast University, self-raised
major depressive disorder (MDD)
 
 
NCT05646264: A Study on the Efficacy of Agomelatine Combined With Antipsychotics to Treat Negative Symptoms in Schizophrenia

Recruiting
4
220
RoW
Agomelatine
Shanghai Mental Health Center, Tianjin Anding Hospital
Schizophrenia, Negative Symptoms in Schizophrenia
08/23
08/23
PRAISED, NCT05426304: Prophylactic Effects of Agomelatine for Poststroke Depression

Not yet recruiting
4
420
NA
Agomelatine, Agomelatine Tablets, Placebo Tablets, Placebo Placebo
First Affiliated Hospital, Sun Yat-Sen University
Depression, Acute Ischemic Stroke
05/24
05/24
ChiCTR-TRC-11001668: Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder.

Completed
3
628
 
Oral Valdoxan, Agomelatine, 25 or 50mg, tablets ;Oral Prozac, Fluoxetine, 20 or 40mg capsules
Institut de Recherche Internationales Servier; Level of the institution：, Institut de Recherche Internationales Servier
Major Depressive Disorder
 
 
2011-005320-17: Effects of agomelatine on emotional experiences in depressed adults patients as compared to escitalopram

Ongoing
3
500
Europe
S20098, S20098, Capsule, VALDOXAN, SEROPLEX, CIPRALEX
Institut de Recherches Internationales Servier, SRDL, Servier Research and Develpment
Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2006-006540-54: Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day).Twelve-week treatment plus double-blind extension for 12 weeks.

Ongoing
3
100
Europe
S20098, S20098, CIPRALEX, CIPRALEX
Institut de Recherches Internationales Servier, Servier Research and Development Limited
Major Depressive Disorder
 
 
2008-003421-17: Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment at 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder.A 12-week randomised, double-blind, placebo-controlled, with paroxetine (20 mg/day with potential progressive blinded adjustment to 40 mg/day) as validator, 3-arm parallel groups, international multicenter study.

Ongoing
3
40
Europe
S20098, S20098, SEROXAT, SEROXAT
Institut de Recherches Internationales Servier
Generalized Anxiety Disorder
 
 
2015-002181-23: Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with moderate to severe Major Depressive Disorder.

Ongoing
3
484
Europe, RoW
Agomelatine, Fluoxetine, S20098, Film-coated tablet, Oral solution, Valdoxan, Fluoxetine
Institut de Recherche International Servier, ADIR
Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2011-003313-42: Agomelatine efficacy of the drug to improve sleep problems in autistic people Eficacia del fármaco agomelatina para mejorar los problemas del sueño en personas autistas

Ongoing
2
40
Europe
Agomelatine, Tablet, Valdoxan 25mg
Hospital General Universitario de Alicante, Hospital General Universitario de Alicante
The treatment of sleep disorders in patients with autism spectrum disorders (ASD) El tratamiento de los trastornos del sueño en los pacientes con trastornos del espectro autista (TEA), The treatment of sleep problems in autistic patients El tratamiento de los problemas del sueño en los pacientes autistas, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2004-002577-23: Efficacy and safety of Agomelatine (25 mg with potential adjustment at 50 mg) given orally once a day for 12 weeks in out-patients with Generalised Anxiety Disorder. A randomised flexible dose double-blind, placebo-controlled, parallel groups, international study.

Ongoing
2
80
Europe
S20098-F55,
Institut de Recherches Internationales Servier
Generalised Anxiety Disorder
 
 
2007-005564-27: Effect of agomelatine (25 mg) given orally once a day for 7 days on cerebral activity measured by functional MRI during processing of emotional stimuli in patients with Major Depressive Disorder. A randomised, double-blind, placebo-controlled study with an open extension period of 6 months with agomelatine (25 mg).Comparison to functional MRI profiles of healthy volunteers.

Ongoing
2
60
Europe
S20098, S20098,
Institut de Recherches Internationales Servier
Major Depressive Disorder
 
 
ChiCTR-TTRCC-13003835: Stuy on the Variability of Agomelatine

Completed
1
16
 
a single oral dose of 25mg agomelatine
the Third Xiangya Hospital of Central South University; the Third Xiangya Hospital of Central South University, This work was supported by the National Scientific Foundation of China (No. 81373476, 81302851, 81301924)
depression
 
 
ChiCTR-TRC-13003179: The different effects of agomelatine and escitalopram on the circadian rhythmic system in the first episode depressive patients

Completed
1
90
 
agomelatine 25-50mg per day before sleep ;escitalopram 10-20mg per day after breakfast ;No intervention
National Institute on Drug Dependence, Peking University; Level of the institution：, Natural Science Foundation of China
Depression
 
 
ChiCTR-IOR-17013734: The control study of mirtazapine and agomelatine on insomnia symptoms in patients with major depressive disorder

Completed
N/A
30
 
mirtazapine versus agomelatine
Peking University Sixth Hospital; Peking University Sixth Hospital, self fund project
major depressive disorder
 
 
ChiCTR2000031387: A retrospective study for the liver safety of agomelatine in the treatment of depression in the real world was analyzed based on the big data model algorithm

Not yet recruiting
N/A
50000
 
N/A ;N/A
Peking University Sixth Hospital; Peking University Sixth Hospital, Horizontal topic
Depressive disorder
 
 
ChiCTR2000037370: A randomized controlled clinical study on the improvement of cognitive impairment in patients with schizophrenia by replacing BDZ with agomelatin

Recruiting
N/A
100
 
Agomelatine ;No intervention
Shanghai Mental Health Center; Shanghai Mental Health Center, Shanghai Shenkang Hospital Development Center
Schizophrenia
 
 
ChiCTR2100046289: Efficacy and safety of agomelatine in patients epilepsy coexisting with depression on mood and cognitive function

Recruiting
N/A
50
 
placebo pill ;agomelatine 25mg ;agomelatine 50mg
Xuanwu Hospital Capital Medical University; Xuanwu Hospital Capital Medical University, research projects
Epilepsy with depression
 
 
NCT05952713: Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder

Completed
N/A
73336
Europe
Antidepressant, sertraline, citalopram, fluoxetine, paroxetine, escitalopram, reboxetine, venlafaxine, duloxetine, mirtazapine, vortioxetine, agomelatine, amitriptyline, imipramine
Mental Health Services in the Capital Region, Denmark, University of Copenhagen
Major Depressive Disorder
07/23
07/23
ChiCTR2000034739: Study on the optimization of treatment scheme for patients with chronic insomnia

Not yet recruiting
N/A
180
 
trazodone ;Mirtazapine ;Fluvoxamine ;CBTI combined with hypnotic therapy ;Agomelatine ;nothing
The Second Affiliated Hospital of Xinxiang Medical University; The Second Affiliated Hospital of Xinxiang Medical University, Not available
Non-organic insomnia
 
 
ChiCTR2400090044: A real-world study of the efficacy and safety of agomelatine in combination with second-generation antipsychotics for the treatment of negative symptoms in patients with schizophrenia

Completed
N/A
80
 
Agomelatine in combination with second-generation antipsychotics; Second-generation antipsychotics alone
Jingzhou Mental Health Center; Jingzhou Mental Health Center, Joint Fund projects
schizofrenia
 
 
ChiCTR2100043512: Effect of agomelatine on cognitive dysfunction in schizophrenia

Recruiting
N/A
120
 
Agomelatine ;none
The Second Affiliated Hospital of Xinxiang Medical College; The Second Affiliated Hospital of Xinxiang Medical University, The Second Affiliated Hospital of Xinxiang Medical University
Schizophrenia
 
 
ChiCTR2200065883: Effects of agomelatine on occurrence of sleep bruxism: preliminary findings

Not yet recruiting
N/A
34
 
Placebo intervention + Agomelatine intervention at least 24 hours after placebo intervention ;Agomelatine intervention + Placebo intervention at least 24 hours after agomelatine intervention
Jiangxi Provincial People's Hospital; Jiangxi Provincial People's Hospital, Jiangxi Provincial People's Hospital Grant 2019-009
Sleep bruxism
 
 
NCT06120543: CYP1A2, ABCB1, CYP2C9 and Plasma Concentration of Agomelatine in Adult Patients With Depression

Not yet recruiting
N/A
50
NA
Affiliated Hospital of Nantong University
Polymorphism, Genetic, Depression, CYP1A2 Polymorphism, CYP2C9 Polymorphism, Polymerase Chain Reaction, Plasma Concentration
12/24
03/25
ChiCTR2300075165: Efficacy and Safety of Agomelatine in Epilepsy Patients With Inpaired Sleep and Mood Disorders: an Observational,Open,and Retrospective study

Recruiting
N/A
280
 
None; None
Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University; Shandong Provincial Hospital, None
Epilepsy Patients With Inpaired Sleep and Mood Disorders
 
 

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