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

Kasper, Siegfried and Hajak, Goeran and Wulff, Katharina and Hoogendijk, Witte J. G. and Luis Montejo, Angel and Smeraldi, Enrico and Rybakowski, Janusz K. and Quera-Salva, Maria-Antonia and Wirz-Justice, Anna M. and Picarel-Blanchot, Francoise and Bayle, Franck 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. JOURNAL OF CLINICAL PSYCHIATRY, 71 (2). pp. 109-120. ISSN 0160-6689, 1555-2101

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Abstract

Objective: This study evaluates the efficacy of agomelatine, the first antidepressant to be an agonist at MT1/MT2 receptors and an antagonist at 5-HT2C 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 I 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 I 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.

Item Type: Article
Uncontrolled Keywords: MOTOR-ACTIVITY; RATING-SCALE; OLDER-ADULTS; SLEEP; ACTIGRAPHY; MELATONIN; AGONIST; ANTAGONIST; FLUOXETINE; DRUGS;
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Psychiatrie und Psychotherapie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 10 Aug 2020 06:22
Last Modified: 10 Aug 2020 06:22
URI: https://pred.uni-regensburg.de/id/eprint/25225

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