Cited by 167Circadian rhythm and melatoninSleep and Work-Related FatigueSleep and related disorders

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Phase‐shifts of 24‐h rhythms of hormonal release and body temperature following early evening administration of the melatonin agonist agomelatine in healthy older men

Leproult, Rachel, Van Onderbergen, Anne, L’Hermite‐Balériaux, Mireille, Van Cauter, Eve, Copinschi, Georges·2005·Clinical Endocrinology

DOI 10.1111/j.1365-2265.2005.02341.x

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Abstract

Summary: Objective Older adults are less responsive to the phase‐shifting effects of light than younger subjects and may have difficulties adapting to abrupt time shifts. This study aims to determine whether the potent melatonin agonist agomelatine (S‐20098) is capable of phase‐shifting overt circadian rhythms in older adults. Subjects and design Eight healthy elderly men participated in a double‐blind, two‐period, cross‐over study of 15 days of daily administration of either agomelatine (50 mg) or placebo at 1830 h. Measurements At the end of each treatment period, the 24‐h profiles of body temperature and of the plasma levels of GH, PRL, cortisol and TSH were collected and sleep was monitored polygraphically. Results Phase‐advances, averaging nearly 2 h, were observed for the temperature profile and for the variables characterizing the temporal organization of cortisol secretion following agomelatine administration. A similar trend was observed for the circadian rise of plasma TSH. There was no effect of agomelatine on any of the sleep variables. Agomelatine stimulated GH secretion during the wake period and was associated with a transient elevation of PRL levels. Conclusions Melatonin agonists such as agomelatine may be useful to phase‐shift at least some overt circadian rhythms in older adults.

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Brown, G. M., Pandi-Perumal, S. R., Trakht, I., & Cardinali, D. P. (2008) · Travel Medicine and Infectious Disease · doi:10.1016/j.tmaid.2008.09.004 · Cited by 56
“Animal studies indicate that agomelatine accelerates re-entrainment of wheel running activity(171) and a study performed in healthy older men indicated that agomelatine phase-shifts 24-h rhythms of hormonal release and body temperature.(172)”
Background
Major depressive disorder: A loss of circadian synchrony?
Edgar, N. M., & McClung, C. A. (2013) · BioEssays · doi:10.1002/bies.201300086 · Cited by 58
“rhythms in slice culture [10], and a newly developed antidepressant, agomelatine, a melatonin receptor agonist, phase advances circadian rhythms in several physiological measures in healthy human subjects [11, 12].”
Background
Parallel Changes in Mood and Melatonin Rhythm Following an Adjunctive Multimodal Chronobiological Intervention With Agomelatine in People With Depression: A Proof of Concept Open Label Study
Robillard, R., Carpenter, J. S., Feilds, K.-L., Hermens, D. F., White, D., Naismith, S. L., Bartlett, D., Whitwell, B., Southan, J., Scott, E. M., et al. (2018) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2018.00624 · Cited by 51
General and comparative efficacy and effectiveness of antidepressants in the acute treatment of depressive disorders: a report by the WPA section of pharmacopsychiatry
Baghai, T. C., Blier, P., Baldwin, D. S., Bauer, M., Goodwin, G. M., Fountoulakis, K. Ν., Kasper, S. F., Leonard, B. E., Malt, U. F., Stein, D. J., et al. (2011) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-011-0259-6 · Cited by 51
“In healthy older men, no effects on normal sleep patterns were found [257], while in patients suffering from MDD in a pilot dose-finding study [264, 265], symptoms related to sleep disturbances such as difficulties in falling asleep, interrupted sleep, shortened sleep, early awakening, and drowsiness decreased substan…”
Background
Social isolation rearing-induced anxiety and response to agomelatine in male and female rats: Role of corticosterone, oxytocin, and vasopressin
Harvey, B. H., Regenass, W., Dreyer, W., & Möller, M. (2019) · Journal of Psychopharmacology · doi:10.1177/0269881119826783 · Cited by 50
“Considering agomelatine’s chronobiotic actions to re-entrain disordered circadian hormones, such as cortisol and melatonin (De Berardis et al., 2015; Leproult et al., 2005), and that it presents with clinically relevant anxiolytic activity (Buoli et al.”
Background
Influence of the novel antidepressant and melatonin agonist/serotonin2C receptor antagonist, agomelatine, on the rat sleep–wake cycle architecture
Descamps, A., Rousset, C., Millan, M. J., Spedding, M., Delagrange, P., & Cespuglio, R. (2009) · Psychopharmacology · doi:10.1007/s00213-009-1519-2 · Cited by 48
“For example, in healthy, elderly men, evening administration of agomelatine led to a phase-shift in circadian rhythms of hormonal release and temperature (Leproult et al. 2005).”
Background
Evaluation of serotonin, noradrenaline and dopamine reuptake inhibitors on light-induced phase advances in hamster circadian activity rhythms
Gannon, R. L., & Millan, M. J. (2007) · Psychopharmacology · doi:10.1007/s00213-007-0903-z · Cited by 47
“A more suitable compound to treat phase delays of seasonal and major depressive disorders would be, for example, the melatonin agonist/ 5-HT2C antagonist, agomelatine (Van Reeth et al. 1997; Krauchi et al. 1997; Leproult et al. 2005; Millan 2005; Fuchs et al. 2006), which is effective in seasonal-affective disorder (P…”
Background
Agomelatine in the tree shrew model of depression: Effects on stress-induced nocturnal hyperthermia and hormonal status
Schmelting, B., Corbach‐Söhle, S., Kohlhause, S., Schlumbohm, C., Flügge, G., & Fuchs, E. (2013) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2013.07.010 · Cited by 44
Agomelatine for the treatment of major depressive disorder
Carney, R. M., & Shelton, R. C. (2011) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2011.607812 · Cited by 44
“These beneficial changes occur as soon as the first week of treatment [33] relative to placebo.”
Background
Agomelatine, a melatonin agonist with antidepressant properties
Dubovsky, S. L., & Warren, C. (2009) · Expert Opinion on Investigational Drugs · doi:10.1517/13543780903292634 · Cited by 45
“In older normal men, 50 mg/day of agomelatine administered in the evening phase advanced rhythms of cortisol, thyroid and body temperature but did not affect sleep [40].”
Background
Antidepressants and Circadian Rhythm: Exploring Their Bidirectional Interaction for the Treatment of Depression
Silva, S., Bicker, J., Falcão, A. C., & Fortuna, A. C. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13111975 · Cited by 49
Circadian clocks, brain function, and development
Frank, E., Sidor, M. M., Gamble, K. L., Cirelli, C., Sharkey, K. M., Hoyle, N. P., Tikotzky, L., Talbot, L. S., McCarthy, M. J., & Hasler, B. P. (2013) · Annals of the New York Academy of Sciences · doi:10.1111/nyas.12335 · Cited by 46
Pharmacological profile of antidepressants: a likely basis for their efficacy and side effects?
Hamon, M., & Bourgoin, S. (2006) · European Neuropsychopharmacology · doi:10.1016/s0924-977x(06)70008-6 · Cited by 42
Melatonin and Melatonin Analogues
Rajaratnam, S. M. W., Cohen, D. A., & Rogers, N. L. (2009) · Sleep Medicine Clinics · doi:10.1016/j.jsmc.2009.02.007 · Cited by 41
Critical appraisal and update on the clinical utility of agomelatine, a melatonergic agonist, for the treatment of major depressive disease in adults
Howland, R. H. (2009) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s5453 · Cited by 38
Agomelatine in the Treatment of Major Depressive Disorder: An Assessment of Benefits and Risks
Gahr, M. (2014) · Current Neuropharmacology · doi:10.2174/1570159x12999140619122914 · Cited by 40
“It was shown that AGM influences circadian rhythms in animals as well as humans [59, 60, 61].”
Background
Agomelatine: The evidence for its place in the treatment of depression
Eser, D. (2009) · Core evidence · doi:10.2147/ce.s6005 · Cited by 37
“The influence of agomelatine 50 mg/day on circadian rhythms was investigated in a double-blind, placebo-controlled, crossover study in healthy, older, adult men.(47) At the end of the 15-day active treatment period, significant 2-hour phase advances in the 24-hour profiles of body temperature and cortisol levels were…”
Clinical Pharmacology of Other Drugs Used as Hypnotics
Buysse, D. J., & Tyagi, S. (2016) · Elsevier eBooks · doi:10.1016/b978-0-323-24288-2.00042-8 · Cited by 34
Mood Disorders, Circadian Rhythms, Melatonin and Melatonin Agonists
Quera-Salva, M.-A., & Hartley, S. (2012) · Journal of Central Nervous System Disease · doi:10.4137/jcnsd.s4103 · Cited by 34
Insomnia in Patients with Depression
Jindal, R. D. (2009) · CNS Drugs · doi:10.2165/00023210-200923040-00004 · Cited by 33
Review: The antidepressant agomelatine improves the quality of life of depressed patients: implications for remission
Llorca, P. (2010) · Journal of Psychopharmacology · doi:10.1177/1359786810372978 · Cited by 31
“, 2009), agomelatine was expected to have a beneficial effect on circadian rhythms and therefore on sleep disturbances (Leproult et al., 2005).”
Background
The effect of melatonergic and non-melatonergic antidepressants on sleep: weighing the alternatives
Pandi-Perumal, S. R., Trakht, I., Srinivasan, V., Spence, D. W., Pöeggeler, B., Hardeland, R., & Cardinali, D. P. (2008) · The World Journal of Biological Psychiatry · doi:10.1080/15622970701625600 · Cited by 30
“0 h (Leproult et al. 2005).”
BackgroundInfluential
Evaluation of agomelatine for the treatment of sleep problems in adults with autism spectrum disorder and co-morbid intellectual disability
Ballester, P., Martínez, M. J., Inda, M., Javaloyes, A., Richdale, A. L., Muriel, J., Belda, C., Toral, N., Morales, D., Fernández, E., et al. (2019) · Journal of Psychopharmacology · doi:10.1177/0269881119864968 · Cited by 30
“An open-label study described a phase advancement of two hours in the temperature rhythm in older men using a larger dose of agomelatine than used here (Leproult et al., 2005).”
Method
Evidence of agomelatine's antidepressant efficacy: the key points
Eser, D., Baghai, T. C., & Möller, H. (2007) · International Clinical Psychopharmacology · doi:10.1097/01.yic.0000277958.83475.d5 · Cited by 30
“In a double-blind, placebo-controlled, crossover study in elderly healthy men (Leproult et al., 2005), agomelatine 50 mg/day significantly phase-advanced the 24-h profiles of body temperature and cortisol levels at the end of a 15-day treatment period.”
Background
Agomelatine and its therapeutic potential in the depressed patient
Kennedy, S. H., & Eisfeld, B. S. (2007) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.a917 · Cited by 29
“With evidence to suggest that disruptions of the internal circadian rhythm system and the sleep-wake cycle may be relevant in the pathoetiology of depression (Boivin 2000), agomelatine should be particularly beneﬁ cial in restoring a healthy sleep-wake cycle.”
Agomelatine treatment corrects impaired sleep-wake cycle and sleep architecture and increases MT1 receptor as well as BDNF expression in the hippocampus during the subjective light phase of rats exposed to chronic constant light
Tchekalarova, J. D., Kortenska, L., Ivanova, N. M., Atanasova, M., & Marinov, P. (2019) · Psychopharmacology · doi:10.1007/s00213-019-05385-y · Cited by 29
Pharmacotherapy of insomnia
Ioachimescu, O., & El-Solh, A. (2008) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2012.683860 · Cited by 122
“It should be noted that, in contrast to antidepressants suppressing monoamine reuptake, agomelatine does not reduce REM sleep either in patients with depression or in healthy volunteers [138].”
Result
Drugs Used in Circadian Sleep-Wake Rhythm Disturbances
Burgess, H. J., & Emens, J. S. (2018) · Sleep Medicine Clinics · doi:10.1016/j.jsmc.2018.02.006 · Cited by 25
Reduced neuroinflammation and enhanced neurogenesis following chronic agomelatine treatment in rats undergoing chronic constant light
Atanasova, D., Lazarov, N., Stoyanov, D. S., Spassov, R. H., Tonchev, A. B., & Tchekalarova, J. D. (2021) · Neuropharmacology · doi:10.1016/j.neuropharm.2021.108706 · Cited by 24
“Thus, by stimulation of MT1 and MT2 receptors, this compound was reported to entrain free-running in rats on the constant dark regime (Martinet et al., 1996) and to advance the circadian phase both in rats and humans (Leproult et al., 2005; Weibel et al., 2000).”
Background
A Functional Polymorphism in the 5HTR2C Gene Associated with Stress Responses Also Predicts Incident Cardiovascular Events
Brummett, B. H., Babyak, M. A., Jiang, R., Shah, S. H., Becker, R. C., Haynes, C. S., Chryst‐Ladd, M., Craig, D. M., Hauser, E. R., Siegler, I. C., et al. (2013) · PLoS ONE · doi:10.1371/journal.pone.0082781 · Cited by 23
“In healthy older men agomelatine treatment was associated with a lower peak cortisol level reached during the morning hours [35].”
Background
Significant role of gene–gene interactions of clock genes in mood disorder
Park, M., Kim, S. A., Yee, J., Shin, J., Lee, K. Y., & Joo, E.-J. (2019) · Journal of Affective Disorders · doi:10.1016/j.jad.2019.06.056 · Cited by 23
Associations of sleep duration with open angle glaucoma in the Korea national health and nutrition examination survey
Lee, J., Han, K., Min, J. A., & Choi, J. A. (2016) · Medicine · doi:10.1097/md.0000000000005704 · Cited by 22
Delayed Sleep-Phase Disorder
Lack, L. C., Wright, H. R., & Bootzin, R. R. (2009) · Sleep Medicine Clinics · doi:10.1016/j.jsmc.2009.01.006 · Cited by 21
The Changes of Expression and Methylation of Genes Involved in Oxidative Stress in Course of Chronic Mild Stress and Antidepressant Therapy with Agomelatine
Wigner, P., Synowiec, E., Jóźwiak, P., Czarny, P. L., Bijak, M., Barszczewska-Pietraszek, G., Białek, K. I., Szemraj, J., Gruca, P., Papp, M., et al. (2020) · Genes · doi:10.3390/genes11060644 · Cited by 20
“Other results showed that melatonin receptor agonists are characterized by ROS scavenging activity and antioxidant system modulation [56] and that the elevated expression of antioxidant enzymes is associated with the activation of melatonin receptors [34].”
Background
Human circadian rhythm studies: Practical guidelines for inclusion/exclusion criteria and protocol
Yousefzadehfard, Y., Wechsler, B., & DeLorenzo, C. (2022) · Neurobiology of Sleep and Circadian Rhythms · doi:10.1016/j.nbscr.2022.100080 · Cited by 22
“…3 months 3 months Yes, personal history of sleep problems 1 week yes yes Lasko, T. A. et al., (Lasko et al., 1999) 1 week Leproult, R. et al., ( Leproult et al., 2005) any, past or current 1 month Liebrich, L. S. et al., ( Liebrich et al., 2014) Yes, PSQI, ESS, LISST Luboshitzky, R. et al., (…”
Behavioral Neurobiology of Bipolar Disorder and its Treatment
Manji, H. K., & Zarate, C. A. (2010) · Current topics in behavioral neurosciences · doi:10.1007/978-3-642-15757-8 · Cited by 20
Dreams, Sleep, and Psychotropic Drugs
Nicolas, A., & Ruby, P. M. (2020) · Frontiers in Neurology · doi:10.3389/fneur.2020.507495 · Cited by 21
“It does not influence REM sleep in depressed patients (99), nor in older healthy subjects (100).”
Background

Authors: Leproult, R., Van Onderbergen, A., L’Hermite‐Balériaux, M., Van Cauter, E., & Copinschi, G.
Affiliations: Université Libre de Bruxelles (BE)
Corresponding author: Leproult, Rachel
ORCID: Leproult, Rachel
Copinschi, Georges
Venue: Clinical Endocrinology
Publisher: Wiley
Published: 2005-08-02
Volume: 63
Issue: 3
Pages: 298-304
ISSN: 0300-0664 (ISSN-L)
1365-2265
DOI: 10.1111/j.1365-2265.2005.02341.x
OpenAlex: W2080424914
Cited by: 167
References: 50
Citations by year: 2026: 1 · 2025: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 7 · 2020: 4 · 2019: 6 · 2018: 7 · 2017: 3 · 2016: 7 · 2015: 7 · 2014: 6 · 2013: 16 · 2012: 7
FWCI: 4.66
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Clinical Endocrinology (publishedVersion)
PubMed (publishedVersion)
Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
Funders: National Institutes of Health
National Institute on Aging (P01AG011412, AG-11412)
Topics: Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Keywords: agomelatine, melatonin receptor agonists, circadian phase shifting, older adults, body temperature rhythm, cortisol secretion, growth hormone, prolactin, thyroid-stimulating hormone, sleep, chronobiology
MeSH terms: Acetamides, Aged, Body Temperature, Circadian Rhythm, Double-Blind Method, Hormones, Humans, Hydrocortisone, Male, Melatonin, Middle Aged, Monitoring, Physiologic, Naphthalenes, Prolactin, Sleep, Growth Hormone, Stimulation, Chemical, Thyrotropin, Cross-Over Studies, Jet Lag Syndrome

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Phase‐shifts of 24‐h rhythms of hormonal release and body temperature following early evening administration of the melatonin agonist agomelatine in healthy older men

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