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Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline.
J Clin Psychiatry. 2010 Feb; 71(2):109-20.JC

Abstract

OBJECTIVE

This study evaluates the efficacy of agomelatine, the first antidepressant to be an agonist at MT(1)/MT(2) receptors and an antagonist at 5-HT(2C) receptors, versus sertraline with regard to the amplitude of the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder (MDD).

METHOD

Outpatients with DSM-IV-TR-defined MDD received either agomelatine 25 to 50 mg (n = 154) or sertraline 50 to 100 mg (n = 159) during a 6-week, randomized, double-blind treatment period. The study was conducted from 2005 to 2006. The main outcome measure was the relative amplitude of the individual rest-activity cycles, expressed as change from baseline to week 6 and collected from continuous records using wrist actigraphy and sleep logs. Secondary outcome measures were sleep efficiency and sleep latency, both derived from actigraphy, and efficacy on depression symptoms (17-Item Hamilton Depression Rating Scale total score and Clinical Global Impressions scale scores) and anxiety symptoms (Hamilton Anxiety Rating Scale total score and subscores).

RESULTS

A significant difference in favor of agomelatine compared to sertraline on the relative amplitude of the circadian rest-activity cycle was observed at the end of the first week (P = .01). In parallel, a significant improvement of sleep latency (P <.001) and sleep efficiency (P <.001) from week 1 to week 6 was observed with agomelatine as compared to sertraline. Over the 6-week treatment period, depressive symptoms improved significantly more with agomelatine than with sertraline (P <.05), as did anxiety symptoms (P <.05).

CONCLUSIONS

The favorable effect of agomelatine on the relative amplitude of the circadian rest-activity/sleep-wake cycle in depressed patients at week 1 reflects early improvement in sleep and daytime functioning. Higher efficacy results were observed with agomelatine as compared to sertraline on both depressive and anxiety symptoms over the 6-week treatment period, together with a good tolerability profile. These findings indicate that agomelatine offers promising benefits for MDD patients.

TRIAL REGISTRATION

www.isrctn.org: ISRCTN49376288.

Authors+Show Affiliations

Department of Psychiatry and Psychotherapy, Medical University Vienna, MUV, AKH, Währinger Gürtel 18-20, A-1090 Wien, Austria. biol-psychiatry@meduniwien.ac.atNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20193645

Citation

Kasper, Siegfried, et al. "Efficacy of the Novel Antidepressant Agomelatine On the Circadian Rest-activity Cycle and Depressive and Anxiety Symptoms in Patients With Major Depressive Disorder: a Randomized, Double-blind Comparison With Sertraline." The Journal of Clinical Psychiatry, vol. 71, no. 2, 2010, pp. 109-20.
Kasper S, Hajak G, Wulff K, et al. Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline. J Clin Psychiatry. 2010;71(2):109-20.
Kasper, S., Hajak, G., Wulff, K., Hoogendijk, W. J., Montejo, A. L., Smeraldi, E., Rybakowski, J. K., Quera-Salva, M. A., Wirz-Justice, A. M., Picarel-Blanchot, F., & Baylé, F. J. (2010). Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline. The Journal of Clinical Psychiatry, 71(2), 109-20. https://doi.org/10.4088/JCP.09m05347blu
Kasper S, et al. Efficacy of the Novel Antidepressant Agomelatine On the Circadian Rest-activity Cycle and Depressive and Anxiety Symptoms in Patients With Major Depressive Disorder: a Randomized, Double-blind Comparison With Sertraline. J Clin Psychiatry. 2010;71(2):109-20. PubMed PMID: 20193645.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline. AU - Kasper,Siegfried, AU - Hajak,Göran, AU - Wulff,Katharina, AU - Hoogendijk,Witte J G, AU - Montejo,Angel Luis, AU - Smeraldi,Enrico, AU - Rybakowski,Janusz K, AU - Quera-Salva,Maria-Antonia, AU - Wirz-Justice,Anna M, AU - Picarel-Blanchot,Françoise, AU - Baylé,Franck J, PY - 2009/05/08/received PY - 2009/11/24/accepted PY - 2010/3/3/entrez PY - 2010/3/3/pubmed PY - 2010/4/23/medline SP - 109 EP - 20 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 71 IS - 2 N2 - OBJECTIVE: This study evaluates the efficacy of agomelatine, the first antidepressant to be an agonist at MT(1)/MT(2) receptors and an antagonist at 5-HT(2C) receptors, versus sertraline with regard to the amplitude of the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder (MDD). METHOD: Outpatients with DSM-IV-TR-defined MDD received either agomelatine 25 to 50 mg (n = 154) or sertraline 50 to 100 mg (n = 159) during a 6-week, randomized, double-blind treatment period. The study was conducted from 2005 to 2006. The main outcome measure was the relative amplitude of the individual rest-activity cycles, expressed as change from baseline to week 6 and collected from continuous records using wrist actigraphy and sleep logs. Secondary outcome measures were sleep efficiency and sleep latency, both derived from actigraphy, and efficacy on depression symptoms (17-Item Hamilton Depression Rating Scale total score and Clinical Global Impressions scale scores) and anxiety symptoms (Hamilton Anxiety Rating Scale total score and subscores). RESULTS: A significant difference in favor of agomelatine compared to sertraline on the relative amplitude of the circadian rest-activity cycle was observed at the end of the first week (P = .01). In parallel, a significant improvement of sleep latency (P <.001) and sleep efficiency (P <.001) from week 1 to week 6 was observed with agomelatine as compared to sertraline. Over the 6-week treatment period, depressive symptoms improved significantly more with agomelatine than with sertraline (P <.05), as did anxiety symptoms (P <.05). CONCLUSIONS: The favorable effect of agomelatine on the relative amplitude of the circadian rest-activity/sleep-wake cycle in depressed patients at week 1 reflects early improvement in sleep and daytime functioning. Higher efficacy results were observed with agomelatine as compared to sertraline on both depressive and anxiety symptoms over the 6-week treatment period, together with a good tolerability profile. These findings indicate that agomelatine offers promising benefits for MDD patients. TRIAL REGISTRATION: www.isrctn.org: ISRCTN49376288. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/20193645/Efficacy_of_the_novel_antidepressant_agomelatine_on_the_circadian_rest_activity_cycle_and_depressive_and_anxiety_symptoms_in_patients_with_major_depressive_disorder:_a_randomized_double_blind_comparison_with_sertraline_ L2 - http://www.psychiatrist.com/jcp/article/pages/2010/v71n02/v71n0202.aspx DB - PRIME DP - Unbound Medicine ER -