TY - JOUR
T1 - Agomelatine in generalized anxiety disorder
T2 - An active comparator and placebo-controlled study
AU - Stein, Dan J.
AU - Ahokas, Antti
AU - Márquez, Miguel S.
AU - Häschl, Cyril
AU - Oh, Kang Seob
AU - Jarema, Marek
AU - Avedisova, Alla S.
AU - Albarran, Cristina
AU - Olivier, Valérie
PY - 2014/4
Y1 - 2014/4
N2 - Background: Agomelatine was efficacious in reducing symptoms in a short-term placebo-controlled trial in generalized anxiety disorder (GAD) and in preventing relapse in a longer term 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 D5M-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. Trial Registration: Control led-Tria ls.com identifier: 1SRCTN03554974.
AB - Background: Agomelatine was efficacious in reducing symptoms in a short-term placebo-controlled trial in generalized anxiety disorder (GAD) and in preventing relapse in a longer term 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 D5M-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. Trial Registration: Control led-Tria ls.com identifier: 1SRCTN03554974.
UR - https://www.scopus.com/pages/publications/84899761273
U2 - 10.4088/JCP.13m08433
DO - 10.4088/JCP.13m08433
M3 - Article
C2 - 24569045
AN - SCOPUS:84899761273
SN - 0160-6689
VL - 75
SP - 362
EP - 368
JO - Journal of Clinical Psychiatry
JF - Journal of Clinical Psychiatry
IS - 4
ER -