Agomelatine for the Treatment of Generalized Anxiety Disorder: A Meta-Analysis
Sheng-Min Wang 1, Young Sup Woo 1, Nak-Young Kim 1, Hae-Ran Na 1, Hyun Kook Lim 1, Won-Myong Bahk 1*
Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea
Received: March 5, 2020; Revised: March 26, 2020; Accepted: March 26, 2020; Published online: March 26, 2020.
© The Korean College of Neuropsychopharmacology. All rights reserved.

Abstract
Objective: Despite multiple drugs available, a large proportion of patients with generalized anxiety disorder (GAD) do not show adequate response and remission. Thus, additional novel pharmacological agents are needed to increase treatment option for GAD. We aimed to investigate efficacy and safety of agomelatine in the treatment of GAD by conducting a meta-analysis.
Methods: An extensive search of multiple databases and clinical trial registries were conducted. Mean change in total scores on Hamilton Anxiety Rating Scale (HAM-A) from baseline to endpoint was out primary outcome measure. Secondary efficacy measures included response and remission rates, as defined by a 50% or greater reduction in HAM-A total scores and a score of 7 or less in HAM-A total scores at study endpoint.
Results: Four published double blinded, randomized, placebo controlled trials (RCTs) were included in this meta-analysis. Agomelatine more significantly (SMD=-0.56, P=0.004) improved HAM-A total scores than placebo. The odds ratios (ORs) of agomelatine over placebo for response and remission rates were 3.75 ( P<0.00001) and 2.74 (P<0.00001), respectively. Agomelatine was generally well tolerated with insignificance in dropout rate, somnolence, headache, nasopharyngitis, and dizziness compared with placebo. However, agomelatine showed significantly higher incidence of liver function increment (OR=3.13, P =0.01) and nausea (OR=3.27, P =0.02).
Conclusion: We showed that agomelatine may be another treatment option in patients with GAD. However, the results should be interpreted and translated into clinical practice with caution because the meta-analysis was based on limited numbers of clinical trials.
Keywords: Agomelatine, Generalized anxiety disorder, Clinical trial, Treatment, Meta-analysis


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