title: Vortioxetine, a multimodal antidepressant for generalized anxiety disorder: a systematic review and meta-analysis.
abstract: Vortioxetine has a beneficial pharmacological profile for reducing anxiety and depression. Recently, a number of randomized, double-blind, placebo-controlled clinical trials (RCTs) of vortioxetine have been conducted in patients with generalized anxiety disorder (GAD); however, the results from GAD RCTs are inconsistent. With an extensive search of databases and clinical trial registries, four published short-term RCTs were identified and included in the present meta-analysis. The mean change in total scores on the Hamilton Anxiety Rating Scale (HAMA) from baseline was the primary endpoint. The secondary endpoints included the response and remission rates, as defined by a ≥50% reduction in HAMA total scores and a ≤7 change in the HAMA total score at the end of treatment. In addition, the mean change in the HAMA total score from baseline in the subgroup with a HAMA total score ≥25 at baseline was included. Vortioxetine was significantly more effective than was placebo, with a standardized mean difference (SMD) of -0.118 (95% CIs, -0.203 to -0.033, P = 0.007). In particular, those with severe GAD (HAMA total score ≥25 at baseline) had a significantly greater benefit from vortioxetine than those without (SMD = -0.338, 95% CIs = -0.552 to -0.124, p = 0.002). The odds ratios (ORs) for vortioxetine for response and remission were 1.221 (95% CIs, 1.027 to 1.452, P = 0.024) and 1.052 (95% CIs, 0.853 to 1.296, P = 0.637), respectively. Discontinuation due to adverse events (AEs) (OR = 1.560, 1.006 to 2.419, p = 0.047) was marginally higher in vortioxetine than placebo treatment, whereas discontinuation due to any reason (OR = 0.971, 0.794 to 1.187, p = 0.771) and inefficacy (OR = 0.687, 0.380 to 1.243, p = 0.215) were not significantly different among treatment groups. Although our results suggest that vortioxetine may have a potential as an another treatment option for GAD (especially for severe GAD), they should be interpreted and translated into clinical practice with caution, as the meta-analysis was based on a limited number of RCTs.
authors: Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea; Department of Psychiatry and Behavioural Sciences, Duke University Medical Center, Durham, NC, USA. Electronic address: pae@catholic.ac.kr.
authors: Chi-Un
authors: CU
authors: Pae
authors: Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.
authors: Sheng-Min
authors: SM
authors: Wang
authors: Department of Psychiatry, Korea University, College of Medicine, Seoul, Republic of Korea.
authors: Changsu
authors: C
authors: Han
authors: Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.
authors: Soo-Jung
authors: SJ
authors: Lee
authors: Department of Psychiatry and Behavioural Sciences, Duke University Medical Center, Durham, NC, USA.
authors: Ashwin A
authors: AA
authors: Patkar
authors: Global Medical Education, New York, NY, USA.
authors: Praksh S
authors: PS
authors: Masand
authors: Institute of Psychiatry, Department of Biomedical and NeuroMotor Sciences, University of Bologna, Bologna, Italy.
authors: Alessandro
authors: A
authors: Serretti
mesh_terms: D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy*; D006801:Humans; D010879:Piperazines / Q000627:therapeutic use*; D013440:Sulfides / Q000627:therapeutic use*; D000078784:Vortioxetine
chemical_list: D014151:Anti-Anxiety Agents; D010879:Piperazines; D013440:Sulfides; D000078784:Vortioxetine
keywords: Efficacy; Generalized anxiety disorder; Meta-analysis; Safety; Tolerability; Vortioxetine