agomelatine / Generic mfg.  >>  Phase 3
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31 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
agomelatine / Generic mfg.
2004-003981-13: A study to determine the maintenance of efficacy of agomelatine (25 mg to 50 mg) to prevent relapse in out-patients with Major Depressive Disorder.A 8 to 10 weeks open period treatment with agomelatine (25 mg to 50 mg) followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.

Completed
3
500
Europe, RoW
S20098-F55, Film-coated tablet
Institut de Recherches Internationales Servier, Servier Research and Development Ltd (for UK only)
Major Depressive Disorder
 
 
2004-004008-19: Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.

Completed
3
500
Europe
S20098, Fluoxetine, S20098, Capsule, hard, PROZAC
Institut de Recherches Internationales Servier, Laboratorios Servier S.L. (For Spain only), SERVIER Research and Development ICTR (For United Kingdom only), INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Severe Major Depressive Disorder
 
 
NCT00411242: Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

Completed
3
503
US
agomelatine, placebo
Novartis
Major Depressive Disorder (MDD)
01/08
 
NCT00411099: Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

Completed
3
508
US
agomelatine, placebo
Novartis
Major Depressive Disorder
01/08
 
NCT00463242: 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)

Completed
3
501
US
Agomelatine, paroxetine, Paxil, placebo
Novartis
Major Depressive Disorder
06/08
 
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
 
 
NCT00467402: Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder

Completed
3
644
US
agomelatine, placebo
Novartis
Major Depressive Disorder
09/09
 
NCT01110902: Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)

Completed
3
589
US
Agomelatine (AGO178C), Placebo
Novartis Pharmaceuticals
Major Depressive Disorder
06/11
06/11
NCT01110889: Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

Completed
3
582
US
Agomelatine (AGO178C), Placebo
Novartis Pharmaceuticals
Major Depressive Disorder
07/11
 
NCT01156415: Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Terminated
3
837
US
AGO178
Novartis Pharmaceuticals
Major Depressive Disorder
10/11
10/11
2009-011795-29: Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.A 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks

Completed
3
210
Europe
S20098, S20098, Film-coated tablet, VALDOXAN
Institut de Recherches Internationales Servier
Major Depression
 
 
2009-011238-84: Efficacy and safety of three dose regimens of agomelatine versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder.

Completed
3
520
Europe, RoW
S20098, S20098, Film-coated tablet, VALDOXAN
Institut de Recherches Internationales Servier, , ADIR
Major Depressive Disorder, Depression, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
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]
 
 
REVIVE, NCT01488071 / 2011-002362-21: A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

Completed
3
495
NA
Vortioxetine (Lu AA21004), Brintellix®, Agomelatine, Valdoxan®
H. Lundbeck A/S
Major Depressive Disorder
12/12
 
2010-023576-10: Comparison of Agomelatine (25 mg/day, adjustement to 50 mg/day) with Escitalopram (10mg/day, adjustement to 20 mg/day) on general interest in outpatients with Major Depressive Disorder over 12 weeks of treatment

Completed
3
300
Europe
S20098, S20098, Film-coated tablet, VALDOXAN, SEROPLEX, CIPRALEX
Institut de Recherches Internationales Servier, ADIR
Major Depressive Disorder, Depression - Psychiatry, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2010-024191-25: Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder.

Completed
3
120
Europe
S20098, S20098, Tablet, VALDOXAN
Institut de Recherches Internationales Servier, ADIR
Major Depressive Disorder, Major Depressive Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
2004-004009-10: Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind international study with parallel groups versus sertraline (50 mg/day with potential adjustment to 100 mg). Six-week treatment plus optional continuation for 18 weeks.

 
3
100
Europe
ZOLOFT, S20098-F56, S20098-F57, GLADEM, GLADEM
Institut de Recherches Internationales Servier, Laboratorios Servier S.L. (For Spain only), INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Major Depressive Disorder
 
03/07
2005-002388-95: Efficacy of agomelatine (25 to 50 mg/day) given orally on quality of remission in elderly depressed patients, after a 12-week treatment period.A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus paroxetine (20 to 30 mg/day).Twelve-week treatment plus optional continuation for 12 weeks.

 
3
80
Europe
Deroxat, Seroxat, S20098-F56, S20098-F57, Deroxat, Seroxat, Deroxat, Seroxat
Institut de Recherches Internationales Servier, Laboratorios Servier S.L. (For Spain only), INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Major Depressive Disorder
 
01/08
2005-004881-17: Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.

 
3
40
Europe
S20098, S20098,
Institut de Recherches Internationales Servier, Laboratorios Servier S.L. (For Spain only)
Major depressive episode in the framework of bipolar disorder
 
12/08
2006-004716-48: Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder.A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months.

 
3
50
Europe
S20098, S20098, CIPRALEX, SEROPLEX, CIPRALEX, SEROPLEX
Institut de Recherches Internationales Servier, Servier Research and Development Limited
Major Depressive Disorder
 
10/08
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
 
 
2006-005674-47: Long-term efficacy and safety of agomelatine in non-depressed out-patients with Generalized Anxiety Disorder.A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25mg/day with the possibility for blinded dose-adjustment to 50mg/day).

 
3
130
Europe
S20098, S20098,
Institut de Recherches Internationales Servier
Generalised anxiety disorder
 
09/09
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
 
 
2008-004642-92: Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder.A randomised, double-blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty-four weeks of treatment.

Completed
3
90
Europe
S20098, CYMBALTA, S20098, VALDOXAN, CYMBALTA, VALDOXAN, CYMBALTA
Laboratorios Servier S.L., Institut de Recherches Internationales Servier, INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Major Depressive Disorder
 
08/10
2009-013789-17: Efficacy and safety of agomelatine for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder.

Completed
3
80
Europe
S20098, S20098, VALDOXAN, CIPRALEX, VALDOXAN, CIPRALEX
Institut de Recherches Internationales Servier, ADIR,
Generalized anxiety disorder
 
07/11
2010-019556-44: Initiation of agomelatine after antidepressant treatment in outpatients suffering major depressive disorder

 
3
80
Europe
S20098, S20098, VALDOXAN, DEROXAT 20 mg, comprimé pelliculé sécable, EFFEXOR L.P. 37,5 mg, gélule à libération prolongée, EFFEXOR L.P. 75 mg, gélule à libération prolongée, VALDOXAN, DEROXAT 20 mg, comprimé pelliculé sécable, EFFEXOR L.P. 37,5 mg, gélule à libération prolongée, EFFEXOR L.P. 75 mg, gélule à libération prolongée
Institut de Recherches Internationales Servier, Laboratorios Servier S.L., INSTITUT DE RECHERCHES INTERNATIONALES SERVIER, ADIR,
Major Depressive Disorder
 
12/11
2012-003699-37: Efficacy and safety of agomelatine (25mg/day with blinded potential adjustment to 50mg/day) versus escitalopram (10mg/day with blinded potential adjustment to 20mg/day) given orally for 12 weeks in non-depressed out-patients with severe Generalized Anxiety Disorder. A 12-week randomised, double-blind, versus escitalopram, 2-arm parallel groups, international multicenter study with a 9-month extension period Hodnocení účinnosti a bezpečnosti agomelatinu (25 mg denně s možností zaslepeného zvýšení na 50 mg denně) oproti escitalopramu (10 mg denně s možností zaslepeného zvýšení na 20 mg denně) po dobu 12 týdnů u ambulantních pacientů s těžkou generalizovanou úzkostnou poruchou bez deprese. 12týdenní, randomizovaná, dvojitě zaslepená, mezinárodní, multicentrická studie s escitalopramem jako srovnávacím přípravkem, se dvěma paralelními skupinami a s možností prodloužení o 9měsíční období.

Completed
3
90
Europe
S20098, S20098, VALDOXAN, SEROPLEX, CIPRALEX, VALDOXAN, SEROPLEX, CIPRALEX
Institut de Recherches Internationales Servier, ADIR
Generalized Anxiety Disorder
 
02/15
2012-001666-15: Efficacy and safety of 2 dose regimens of agomelatine (10 mg/day or 25 mg/day) versus placebo given orally for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder

Completed
3
60
Europe
S20098, S20098, VALDOXAN, VALDOXAN
Institut de Recherches Internationales Servier, ADIR
Generalized Anxiety Disorder
 
01/15
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]
 
 
NCT02374567: Pharmacovigilance in Gerontopsychiatric Patients

Terminated
3
407
Europe
Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Valproic Acid, Lamotrigine, Topiramate, Gabapentin, Levetiracetam, Pregabalin, Lacosamide, Clonazepam, Biperiden, Levomepromazine, Fluphenazine, Perphenazine, Perazine, Thioridazine, Haloperidol, Melperone, Pipamperone, Bromperidol, Benperidol, Sertindole, Ziprasidone, Flupentixol, Chlorprothixene, Zuclopenthixol, Fluspirilene, Pimozide, Clozapine, Olanzapine, Quetiapine, Sulpiride, Tiapride, Amisulpride, Prothipendyl, Risperidone, Aripiprazole, Paliperidone, Diazepam, Oxazepam, Lorazepam, Bromazepam, Clobazam, Alprazolam, Hydroxyzine, Buspirone, Chloral Hydrate, Flurazepam, Nitrazepam, Triazolam, Lormetazepam, Temazepam, Midazolam, Brotizolam, Zopiclone, Zolpidem, Zaleplon, Melatonin, Clomethiazole, Diphenhydramine, Promethazine, Imipramine, Clomipramine, Opipramol, Trimipramine, Amitriptyline, Nortriptyline, Doxepin, Maprotiline, Amitriptyline oxide, Fluoxetine, Citalopram, Paroxetine, Sertraline, Fluvoxamine, Escitalopram, Tranylcypromine, Moclobemide, Mianserin, Trazodone, Mirtazapine, Bupropion, Venlafaxine, Reboxetine, Duloxetine, Agomelatine, Pyritinol, Piracetam, Donepezil, Rivastigmine, Galantamine, Memantine, Nicergoline, Acamprosate, Lithium
Hannover Medical School
Dementia, Depression, Schizophrenia, Psychosomatic Disorders, Anxiety Disorders
06/17
06/17
NCT03852160: 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

Withdrawn
3
0
NA
Esketamine 28 mg, JNJ-54135419, Esketamine 56 mg, Esketamine 84 mg, Placebo, Escitalopram, Sertraline, Duloxetine, Mirtazapine, Agomelatine, Bupropion, Trazodone Prolonged Release
Janssen-Cilag International NV
Depressive Disorder, Treatment-Resistant
07/21
07/21

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