Агомелатин, первый мелатонинергический антидепрессант: открытие, характеристики и развитие

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Идентификация агомелатина как высоко потенциального лиганда мелатонинергических рецепторов.

  1. Van Reeth, O. et al. Comparative effects of a melatonin agonist on the circadian system in mice and syrian hamsters. Brain Res. 762, 185-194 (1997).

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Подтверждение свойств агомелатина как агониста популяции мелатонинергических рецепторов в супрахиазматическом ядре.

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  4. Gerdin, M. J. et al. Melatonin desensitizes endogenous MT2 melatonin receptors in the rat suprachiasmatic nucleus: relevance for defining the periods of sensitivity of the mammalian circadian clock to melatonin. FASEB J. 18, 1646-1656 (2004).

  5. Ying, S. W., Rusak, B. & Mocaer, E. Chronic exposure to melatonin receptor agonists does not alter their effects on suprachiasmatic nucleus neurons. Eur. J. Pharmacol. 342, 29-37 (1998).

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In vivo исследование, подтверждающее, что агомелатин эффективно корректирует циркадианные ритмы.

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  7. Wirz-Justice, A. et al. Early evening melatonin and, S20098 advance circadian phase and nocturnal regulation of core body temperature. Am. J. Physiol. 272, R1178-R1188 (1997).

  8. Redman, J. R. & Francis, A. J. Entrainment of rat circadian rhythms by the melatonin agonist, S20098 requires intact suprachiasmatic nuclei but not the pineal. J. Biol. Rhythms 13, 39-51 (1998).

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  11. Cajochen, C., Krauchi, K., Mori, D., Graw, P. & Wirz-Justice, A. Melatonin and S20098 increase REM and wake-up propensity without modifying NREM sleep homeostasis. Am. J. Physiol. Regul. Integrative Comp. Physiol. 272, R1189-R1196 (1997).

  12. Krauchi, K., Cajochen, C., Mori, D., Graw, P. & Wirz-Justice, A. Early evening melatonin and S20098 advance circadian phase and nocturnal regulation of core body temperature. Am. J. Physiol. Regul. Integrative Comp. Physiol. 272, R1178-R1188 (1997).

Исследование, подтверждающее, что у здоровых добровольцев при вечернем назначении агомелатин достоверно и стойко влияет на циркадианные ритмы в течение 24 часов.

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Подтверждение, что агомелатин действует как антагонист клонированных, человеческих и нативных 5-HT2C рецепторов головного мозга.

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  7. Gannon, R. L. & Millan, M. J. Serotonin1A autoreceptor activation by, S15535 enhances circadian activity rhythms in hamsters: evaluation of potential interactions with serotonin2A and serotonin2C receptors. Neuroscience 137, 287-299 (2006).

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  10. Linnik, l. V. et al. The novel antidepressant, agomelatine, blocks cerebral 5-HT2C receptors in vivo: a phMRl challenge study in rats. Eur. Neuropsychopharmacol. 19, S259 (2009).

  11. Papp, M., Gruca, P., Boyer, P. A. & Mocaer, E. Effect of agomelatine in the chronic mild stress model of depression in the rat. Neuropsychopharmacology 28, 694-703 (2003).

Модель ангедонии - первое доказательство, что агомелатин обладает отчетливыми антидепрессивными свойствами, которые реализуются за счет механизма взаимодействия мелатонинергических и 5-HT2C рецепторов.

  1. Bourin, M., Mocaer, E. & Porsolt, R. Antidepressant-like activity of S20098 (agomelatine) in the forced swimming test in rodents: involvement of melatonin and serotonin receptors. J. Psychiatry Neurosci. 29, 126-133 (2004).

  2. Alex, K. D. & Pehek, E. A. Pharmacological mechanisms of serotonergic regulation of dopamine neurotransmission. Pharmacol. Ther. 11 3, 296-320 (2007).

  3. Banasr, M., Hery, M., Mocaer, E. & Daszuta, A. Agomelatine, a new antidepressant drug, increases cell proliferation, maturation and survival of newly generated granule cells in adult hippocampus. Biol. Psychiatry 59, 1087-1096 (2006).

Длительная терапия агомелатином усиливает клеточную пролиферацию и нейрогенез в гиппокампе - механизм, свойственный антидепрессантам других классов и участвующий в улучшении настроения.

  1. Soumier, A. et al. Mechanisms contributing to the phase-dependent regulation of neurogenesis by the novel antidepressant, agomelatine, in the adult rat hippocampus. Neuropsychopharmacology 34, 2390-2403 (2009).

  2. Barden, N. et al. Antidepressant action of agomelatine (S20098) in a transgenic mouse model. Prog. Neuropsychopharmacol. Biol. Psychiatry 29, 908-916 (2005).

  3. Norman, T. R., Cranston, l. & lrons, J. Effect of the novel antidepressant agomelatine in the olfactory bulbectomised rat. Int. J. Neuropsychopharmacol. 7, S461 (2004).

  4. Dekeyne, A. et al. S32006, a novel 5-HT2C receptor antagonist displaying broad-based antidepressant and anxiolytic properties in rodent models. Psychopharmacology 199, 549-568 (2008).

  5. Bertaina-Anglade, V., la Rochelle, C. D., Boyer, P. A. & Mocaer, E. Antidepressant-like effects of agomelatine (S20098) in the learned helplessness model. Behav. Pharmacol. 17, 703-713 (2006).

  6. Corbach, S., Schmelting, B., Fuchs, E. & Mocaer, E. Comparison of agomelatine and melatonin for effects in chronically stressed tree shrews, an animal model of depression. Eur. Neuropsychopharmacol. 17, S364 (2007).

  7. Corbach-Sohle, S. et al. Effects of agomelatine and S32006, a selective 5-HT2C receptor antagonist, in chronically-stressed tree shrews. Eur. Neuropsychopharmacol. 18, S348 (2008).

  8. Overstreet, D. H., Pucilowski, O., Rettori, M. C., Delagrange, P. & Guardiola-Lemaitre, B. Effects of melatonin receptor ligands on swim test immobility. Neuroreport 29, 249-253 (1998).

  9. Weil, Z. M., Hotchkiss, A. K., Gatien, M. L., Pieke-Dahl, S. & Nelson, R. J. Melatonin receptor (MT1) knockout mice display depression-like behaviours and deficits in sensorimotor gating. Brain Res. Bull. 68, 425-429 (2006).

  10. Olie, J. P. & Kasper, S. Efficacy of agomelatine, a MT1/MT2 receptor agonist with 5-HT2C antagonistic properties, in major depressive disorder. Int. J. Neuropsychopharmacol. 10, 661-673 (2007).

  11. Descamps, A. et al. lnfluence of the novel antidepressant and melatonin agonist/serotonin2C receptor antagonist, agomelatine, on the rat sleep-wake cycle architecture. Psychopharmacology 205, 93-106 (2009).

  12. Quera-Salva, M. A. et al. Major depressive disorder, sleep EEG and agomelatine: an open-label study. Int. J. Neuropsychopharmacol. 10, 691-696 (2007).

  13. Wilson, S. & Argyropoulos, S. Antidepressants and sleep: a qualitative review of the literature. Drugs 65, 927-947 (2005).

  14. Leproult, R., Van Onderbergen, A., L'Hermite-Baleriaux, M., Van Cauter, E. & Copinschi, G. Phase-shifts of 24h rhythms of hormonal release and body temperature following early evening administration of the melatonin agonist agomelatine in healthy older men. Clin. Endocrinol. 63, 298-304 (2005).

  15. Kennedy, S. J. & Rizvi, S. J. Agomelatine in the treatment of major depressive disorder: potential for clinical effectiveness. CNS Drugs 24, 479-499 (2010).

  16. Loo, H., Hale, A. & D'haenen, H. Determination of the dose of agomelatine, a melatonergic agonist and selective 5-HT2C antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study. Int. Clin. Psychopharmacol. 17, 239-247 (2002).

Основные исследования, подтверждающие клиническую ценность агомелатина в терапии большой депрессии.

  1. Leuchter, A. F. et al. Pretreatment neurophysiological and clinical characteristics of placebo responders in treatment trials for major depression. Psychopharmacology 177, 15-22 (2004).

  2. Berk, M. & Dodd, S. Antidepressants and the placebo response. Hum. Psychopharmacol. Clin. Exp. 20, 305-307 (2005).

  3. Kennedy, S. H. & Emsley, R. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur. Neuropsychopharmacol. 16, 93-100 (2006).

  4. Lemoine, P., Guilleminault, C. & Alvarez, E. lmprovement in subjective sleep in major depressive disorder with a novel antidepressant, agomelatine: randomized, double blind comparison with venlafaxine. J. Clin. Psychiatry 68, 1723-1732 (2007).

  5. Kasper, S. et al. Efficacy of the novel antidepressant agomelatine on the circadian and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline. J. Clin. Psychiatry 71 , 109-120 (2010).

  6. Kennedy, S. H., Rizvi, S., Fulton, K. & Rasmussen, J. A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR. J. Clin. Psychopharmacol. 28, 329-333 (2008).

  7. Srinivasan, V. et al. Pathophysiology of depression: role of sleep and the melatonergic system. Psychiatry Res. 165, 201-214 (2009).

  8. Goodwin, G. M., Emsley, R., Rembry, S., Rouillon, F. & Agomelatine Study Group. Agomelatine prevents relapse in patients with major depressive disorder without evidence of a discontinuation syndrome: a 24-week randomized, double-blind, placebo-controlled trial. J. Clin. Psychiatry 70, 1128-1137 (2009).

Антидепрессивный эффект агомелатина стойко сохраняется в течение 6 месяцев терапии и определяет его эффективность в профилактике рецидивов.

  1. Goodwin, G., Rouillon, F. & Emsley, R. Long-term treatment with agomelatine: prevention of relapse in patients with major depressive disorder over 10 months. Eur. Neuropsychopharmacol. 18, S338 (2009).

  2. Montgomery, S. A., Kennedy, S. H., Burrows, G. D., Lejoyeux, M. & Hindmarch, l. Absence of discontinuation symptoms with agomelatine and occurrence of discontinuation symptoms with paroxetine: a randomized, double-blind, placebo-controlled discontinuation study. Int. Clin. Psychopharmacol. 19, 271-280 (2004).

Подтверждение того, что резкоая остановка терапия агомелатином при большой депрессии не приводит к развитию симптомов отмены в отличие от СИОЗС пароксетина.

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  2. Aronne, L. J. & Segal, K. R. Weight gain in the treatment of mood disorders. J. Clin. Psychiatry. 64 (Suppl. 8), 22-29 (2003).

  3. Serretti, A. & Chiesa, A. Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis. J. Clin. Psychopharmacol. 29, 259-266 (2009).

  4. Drago, F. & Busa, L. Acute low doses of melatonin restore full sexual activity in impotent male rats. Brain Res. 878, 98-104 (2000).

  5. Brotto, L. A., Gorzalka, B. B. & LaMarre, A. K. Melatonin protects against the effects of chronic stress on sexual behaviour in male rats. Neuroreport 12, 3465-3469 (2001).

  6. Hull, E. M., Muschamp, J. W. & Sato, S. Dopamine and serotonin influences on male sexual behaviour. Physiol. Behav. 83, 291-307 (2004).

  7. Montejo, A. et al. Better sexual acceptability of agomelatine (25 and 50 mg) compared with paroxetine (20 mg) in healthy male volunteers. An 8-week, placebo-controlled study using the PRSEXDQ-SALSEX scale. J. Psychopharmacol. 24, 111-120 (2009).

  8. Musazzi, L. et al. Stress increases depolarization-evoked glutamate release in the rat prefrontal/frontal cortex: the dampening action of antidepressants. PLoS One 5, e8566 (2010).

  9. Walker, M. P. & Stickgold, R. Sleep, memory, and plasticity. Annu. Rev. Psychol. 57, 139-166 (2006).

  10. Bruel-Jungerman, E., Rampon, C. & Laroche, S. Adult hippocampal neurogenesis, synaptic plasticity and memory: facts and hypotheses. Rev. Neurosci. 18, 93-114 (2007).

  11. Eckel-Mahan, K. L. & Storm, D. R. Circadian rhythms and memory: not so simple as cogs and gears. EMBO Rep. 10, 584-591 (2009).

  12. Austin, M. P., Mitchell, P. & Goodwin, G. M. Cognitive deficits in depression: possible implications for functional neuropathology. Br. J. Psychiatry 178, 200-206 (2001).

  13. Conboy, L. et al. The antidepressant agomelatine blocks the adverse effects of stress on memory and enables spatial learning to rapidly increase neural cell adhesion molecule (NCAM) expression in the hippocampus of rats. Int. J. Neuropsychopharmacol. 12, 329-341 (2009).

  14. Castro-Costa, E. et al. Prevalence of depressive symptoms and syndromes in later life in ten European countries, the SHARE study. Br. J. Psychiatry 191, 393-401 (2007).

  15. Magnusson, A. & Partonen, T. The diagnosis, symptomatology, and epidemiology of seasonal affective disorder. CNS Spectr. 10, 625-634 (2005).

  16. Pjrek, E. et al. Agomelatine in the treatment of seasonal affective disorder. Psychopharmacology 190, 575-579 (2007).

  17. Schoevers, R. A., Van, H. L., Koppelmans, V., Kool, S. & Dekker, J. J. Managing the patient with co-morbid depression and an anxiety disorder. Drugs 68, 1621-1634 (2008).

  18. Tuma, J., Strubbe, J. H., Mocaer, E. & Koolhaas, J. M. Anxiolytic-like action of the antidepressant agomelatine (S20098) after a social defeat requires the integrity of the SCN. Eur. Neuropsychopharmacol. 15, 545-555 (2005).

  19. Heisler, L. K., Zhou, L., Bajwa, P., Hsu, J. & Tecott, L. H. Serotonin 5-HT2C receptors regulate anxiety-like behaviour. Genes Brain Behav. 6, 491-496 (2007).

  20. Millan, M. J., Brocco, M., Gobert, A. & Dekeyne, A. Anxiolytic properties of agomelatine, and antidepressant with melatonergic and serotonergic properties: role of 5-HT2C receptor blockade. Psychopharmacology 177, 448-458 (2005).

  21. Papp, M., Litwa, E., Gruca, P. & Mocaer, E. Anxiolytic-like activity of agomelatine and melatonin in three animal models of anxiety. Behav. Pharmacol. 17, 9-18 (2006).

  22. Stein, D. J., Ahokas, A. A. & de Bodinat, C. Efficacy of agomelatine in generalized anxiety disorder: a randomized, double-blind, placebo-controlled study. J. Clin. Psychopharmacol. 28, 561-566 (2008).

Первое подтверждение клинической эффективности агомелатина в терапии генерализованного тревожного расстройства.

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  2. Srinivasan, V. et al. Melatonin in mood disorders. World J. Biol. Psychiatry 7, 138-151 (2006).

  3. Luo, A. H. & Aston-Jones, G. Circuit projection from suprachiasmatic nucleus to ventral tegmental area: a novel circadian output pathway. Eur. J. Neurosci. 29, 748-760 (2009).

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