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