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Statements

Subject Item
n2:RIV%2F00216208%3A11120%2F14%3A43908952%21RIV15-MSM-11120___
rdf:type
skos:Concept n15:Vysledek
dcterms:description
An additional short-term placebo-controlled study is required by regulatory agencies to confirm the efficacy of agomelatine in GAD. Method: This 12-week, placebo-controlled, double-blind, randomized, parallel group, international, multicenter study was designed to confirm the efficacy of agomelatine 25-50 mg/d in the treatment of patients with a primary DSM-IV-TR diagnosis of GAD. The primary outcome measure was the Hamilton Anxiety Rating Scale (HARS) total score. Assay sensitivity was evaluated by including an escitalopram (10-20 mg/d) group. Settings: The study was undertaken in 45 clinical centers in Argentina, Czech Republic, Finland, South Korea, Poland, Russia, and Slovakia from April 2010 to July 2011. Results: One hundred thirty-nine outpatients were included in the agomelatine group, 131 in the placebo group, and 142 in the escitalopram group. Agomelatine significantly reduced mean (SD) HARS total score (agomelatine-placebo difference: 4.71 [1.03], P < .0001) and had significant effects on secondary outcome measures, including psychic and somatic HARS subscales, response rate (estimate [standard error]) (agomelatine-placebo difference: 27.4% [5.9%], P < .0001), remission on the HARS (agomelatine-placebo difference: 16.8% [5.4%], P = .002), Clinical Global Impressions-Severity of Illness scale (CGI-S) (P < .001), functional impairment (P < .0001), and sleep quality (P < .001). Findings were confirmed in the subset of more severely ill patients (HARS total score >= 25 with or without CGI-S >= 5 at baseline). Agomelatine was well tolerated by patients, with no more adverse events than placebo. Escitalopram was similarly efficacious but was accompanied by a higher incidence of adverse events compared to placebo. Conclusions: In clinical practice, agomelatine has at least similar efficacy to that of escitalopram for the short-term treatment of GAD and is well tolerated. An additional short-term placebo-controlled study is required by regulatory agencies to confirm the efficacy of agomelatine in GAD. Method: This 12-week, placebo-controlled, double-blind, randomized, parallel group, international, multicenter study was designed to confirm the efficacy of agomelatine 25-50 mg/d in the treatment of patients with a primary DSM-IV-TR diagnosis of GAD. The primary outcome measure was the Hamilton Anxiety Rating Scale (HARS) total score. Assay sensitivity was evaluated by including an escitalopram (10-20 mg/d) group. Settings: The study was undertaken in 45 clinical centers in Argentina, Czech Republic, Finland, South Korea, Poland, Russia, and Slovakia from April 2010 to July 2011. Results: One hundred thirty-nine outpatients were included in the agomelatine group, 131 in the placebo group, and 142 in the escitalopram group. Agomelatine significantly reduced mean (SD) HARS total score (agomelatine-placebo difference: 4.71 [1.03], P < .0001) and had significant effects on secondary outcome measures, including psychic and somatic HARS subscales, response rate (estimate [standard error]) (agomelatine-placebo difference: 27.4% [5.9%], P < .0001), remission on the HARS (agomelatine-placebo difference: 16.8% [5.4%], P = .002), Clinical Global Impressions-Severity of Illness scale (CGI-S) (P < .001), functional impairment (P < .0001), and sleep quality (P < .001). Findings were confirmed in the subset of more severely ill patients (HARS total score >= 25 with or without CGI-S >= 5 at baseline). Agomelatine was well tolerated by patients, with no more adverse events than placebo. Escitalopram was similarly efficacious but was accompanied by a higher incidence of adverse events compared to placebo. Conclusions: In clinical practice, agomelatine has at least similar efficacy to that of escitalopram for the short-term treatment of GAD and is well tolerated.
dcterms:title
Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study
skos:prefLabel
Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study
skos:notation
RIV/00216208:11120/14:43908952!RIV15-MSM-11120___
n3:aktivita
n10:N
n3:aktivity
N
n3:cisloPeriodika
4
n3:dodaniDat
n12:2015
n3:domaciTvurceVysledku
n16:1371576
n3:druhVysledku
n6:J
n3:duvernostUdaju
n13:S
n3:entitaPredkladatele
n14:predkladatel
n3:idSjednocenehoVysledku
1876
n3:idVysledku
RIV/00216208:11120/14:43908952
n3:jazykVysledku
n17:eng
n3:klicovaSlova
escitalopram; mental-disorders; controlled discontinuation; antidepressant agomelatine; dsm-iv; pharmacological-treatment; major depressive disorder; international neuropsychiatric interview
n3:klicoveSlovo
n7:mental-disorders n7:controlled%20discontinuation n7:pharmacological-treatment n7:escitalopram n7:dsm-iv n7:major%20depressive%20disorder n7:international%20neuropsychiatric%20interview n7:antidepressant%20agomelatine
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[BA21A543B108]
n3:nazevZdroje
Journal of Clinical Psychiatry
n3:obor
n8:FL
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
9
n3:rokUplatneniVysledku
n12:2014
n3:svazekPeriodika
75
n3:tvurceVysledku
Höschl, Cyril
n3:wos
000336525700011
s:issn
0160-6689
s:numberOfPages
7
n11:doi
10.4088/JCP.13m08433
n18:organizacniJednotka
11120