"9"^^ . "H\u00F6schl, Cyril" . "RIV/00216208:11120/14:43908952!RIV15-MSM-11120___" . "Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study" . "0160-6689" . "000336525700011" . . "N" . "RIV/00216208:11120/14:43908952" . . . "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."@en . "[BA21A543B108]" . "Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study"@en . . . . "1"^^ . "10.4088/JCP.13m08433" . "Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study"@en . . . . . . . "Journal of Clinical Psychiatry" . "Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study" . . . "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." . "escitalopram; mental-disorders; controlled discontinuation; antidepressant agomelatine; dsm-iv; pharmacological-treatment; major depressive disorder; international neuropsychiatric interview"@en . "US - Spojen\u00E9 st\u00E1ty americk\u00E9" . . "4" . "7"^^ . "75" . . . "1876" . . . "11120" .